Climara Pro

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Climara Pro

What is Climara Pro

Levonorgestrel

The Generic name of this drug

Treatment Summary

Estradiol is a hormone naturally found in females. It is available as a prescription medication to treat conditions caused by low estrogen levels, such as hot flashes and vulvovaginal atrophy. Estradiol can be taken orally, by injection, through a vaginal ring, patch, spray, gel, or cream. It is often combined with a pro-drug ester, such as ethinyl estradiol, to make it more effective when taken orally. Ethinyl estradiol is a synthetic form of estradiol that is commonly used in combination oral contraceptive pills.

Triphasil-21

is the brand name

image of different drug pills on a surface

Climara Pro Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Triphasil-21

Levonorgestrel

1984

243

Approved as Treatment by the FDA

Levonorgestrel, also known as Triphasil-21, is approved by the FDA for 7 uses including Osteoporosis, Postmenopausal and Menopause .

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

Menopause

Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol

Has had at least 1 child

Emergency Contraception

Hot flashes

Used to treat Menopause in combination with Estradiol

Effectiveness

How Climara Pro Affects Patients

Estradiol is used to treat symptoms related to menopause, such as hot flashes and vaginal dryness. It can also improve bone density by reducing bone resorption, and can raise levels of proteins like sex hormone binding globulin. Taking estradiol may also cause an increase in follicle-stimulating hormone. However, estradiol should be avoided by people at high risk of cardiovascular disease, deep vein thrombosis, or stroke, as it can cause a hyper-coagulable state. Additionally, taking estradiol may raise blood pressure due to an increase in angiotensin

How Climara Pro works in the body

Estrogen is a hormone found in many parts of the body. In women, most of it is produced by the ovaries before menopause. After menopause, the majority of estrogen comes from the adrenal glands. Estrogen works by binding to two types of receptors, ERα and ERβ, and by stimulating the G Protein-coupled estrogen receptor. This causes the receptor to enter the nucleus of the target cell and regulate gene transcription. As a result, proteins are produced that have specific effects on the target cells. This leads to relief of common symptoms associated with low estrogen levels such as hot flashes, chills

When to interrupt dosage

The suggested dosage of Climara Pro is reliant upon the diagnosed disorder, such as Premature Menopause, Pharmaceutical Preparations and Postmenopause. The quantity of dosage varies, according to the method of delivery detailed in the table below.

Condition

Dosage

Administration

Osteoporosis, Postmenopausal

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Endometrial Hyperplasia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Endometriosis

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Hot flashes

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Emergency Contraception

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Menopause

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Menorrhagia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Has had at least 1 child

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

moderate Menopausal Vasomotor Symptoms

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Implant, Tablet, film coated - Oral, Tablet, film coated

Warnings

Climara Pro has eighteen contraindications, and should not be administered if you are suffering from any of the afflictions listed in the table below.

Climara Pro Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Levonorgestrel may interact with Pulse Frequency

Abortion, Septic

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Abortion, Spontaneous

Do Not Combine

HCG elevated

Do Not Combine

Pelvic Infection

Do Not Combine

Vaginitis

Do Not Combine

Acute Coryza

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervicitis

Do Not Combine

Communicable Diseases

Do Not Combine

Gonorrhea

Do Not Combine

Breast Cancer

Do Not Combine

Intrauterine Devices

Do Not Combine

Liver Neoplasms

Do Not Combine

congenital or aquired uterine abnormality

Do Not Combine

Chlamydia Infections

Do Not Combine

Hypersensitivity

Do Not Combine

Emergency Contraception

Do Not Combine

Endocarditis, Bacterial

Do Not Combine

Vaginosis, Bacterial

Do Not Combine

suspected pregnancy

Do Not Combine

Uterine Cervicitis

Do Not Combine

Uterine Neoplasms

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervical Neoplasms

Do Not Combine

Fibroid Tumor

Do Not Combine

Endometritis

Do Not Combine

chlamydial cervical infection

Do Not Combine

PAP Test Abnormalities

Do Not Combine

Liver Failure, Acute

Do Not Combine

Uterine anomaly distorting uterine cavity

Do Not Combine

Breast Cancer

Do Not Combine

Cervical Dysplasia

Do Not Combine

Thromboembolism

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast

Do Not Combine

Vaginal Bleeding

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Gonorrhea

Do Not Combine

There are 20 known major drug interactions with Climara Pro.

Common Climara Pro Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Levonorgestrel.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Levonorgestrel.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Levonorgestrel.

Copanlisib

Major

The metabolism of Copanlisib can be decreased when combined with Levonorgestrel.

Crizotinib

Major

The metabolism of Crizotinib can be decreased when combined with Levonorgestrel.

Climara Pro Toxicity & Overdose Risk

In rats, the highest dose of estradiol without causing harm was 0.003mg/kg per day. The lowest toxic dose in women is 21mg/kg, and the highest toxic dose in rats is 960mg/kg. If someone has an overdose of estradiol, they may experience nausea, vomiting, abdominal pain, breast tenderness, blood clots, and vaginal bleeding. Treatment for estradiol overdose includes discontinuing the medication and providing supportive care.

image of a doctor in a lab doing drug, clinical research

Climara Pro Novel Uses: Which Conditions Have a Clinical Trial Featuring Climara Pro?

867 active trials are currently being conducted to assess the efficacy of Climara Pro in treating Osteoporosis, Secondary Amenorrhea and Urogenital Atrophy.

Condition

Clinical Trials

Trial Phases

Endometriosis

30 Actively Recruiting

Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4

Hot flashes

19 Actively Recruiting

Not Applicable, Phase 2, Phase 4, Early Phase 1, Phase 3

Menorrhagia

3 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Has had at least 1 child

0 Actively Recruiting

Endometrial Hyperplasia

3 Actively Recruiting

Not Applicable, Phase 2, Phase 3

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Menopause

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Emergency Contraception

1 Actively Recruiting

Phase 4

Climara Pro Reviews: What are patients saying about Climara Pro?

5

Patient Review

8/18/2022

Climara Pro for "Change of Life" Signs

I find the patch very convenient to use. I change it once a week, on what I like to call "Menopause Monday." I haven't experienced any weight gain or loss since starting this treatment, but my brain fog, vaginal dryness, and sweats have all improved. I generally feel like my old self again with more energy.

5

Patient Review

3/8/2022

Climara Pro for "Change of Life" Signs

I started seeing results within a week, and they just kept getting better and better. I did experience some light vaginal bleeding at the five-week mark, but my doctor says that's normal and nothing to worry about.

4.3

Patient Review

12/7/2018

Climara Pro for "Change of Life" Signs

I had good results from this patch, but after a few months of use I started to experience some skin irritation. I'm hoping there's a milder solution out there that can give me the same peace and calm without the side effects.

4

Patient Review

7/22/2018

Climara Pro for "Change of Life" Signs

This medication has been working great for me and has helped to lessen my bipolar II symptoms. I haven't experienced any negative side effects, which is amazing. Additionally, I found that keeping the patches away from heat seems to help with attachment problems.

3.7

Patient Review

8/8/2019

Climara Pro for "Change of Life" Signs

I started using Climara Pro to mitigate my menopause symptoms, which it did to some extent. However, I have been experiencing vaginal bleeding for the past two months. My doctor says everything looks okay, but I really wish the bleeding would stop. Additionally, the patch could use more adhesive; it often falls off during hot summer months.

3

Patient Review

5/28/2018

Climara Pro for Post-Menopausal Osteoporosis Prevention

It's really frustrating how hard it is to peel the backing off these patches. I've wasted so many because of it. That said, my bone density reports have been good since starting this medication, so I guess it's a love-hate relationship.

3

Patient Review

4/22/2022

Climara Pro for "Change of Life" Signs

While this treatment was initially effective in managing my mood swings and hot flashes, I began to experience uncontrollable hunger which led to rapid weight gain. Consequently, I had to stop using the patch.

2.7

Patient Review

5/23/2022

Climara Pro for "Change of Life" Signs

I found this product effective for menopause symptoms like hot flashes and body aches. However, I stopped using it after 8 months because I felt like it was making me forgetful. According to my research, early dementia is a side effect of this medication—and that's something I'd rather avoid in exchange for the hot flashes.

2.3

Patient Review

3/1/2021

Climara Pro for "Change of Life" Signs

Out of the three boxes I received, only one had patches that actually worked. And even then, it killed my sex drive. So while it did help with hot flashes, I can't in good faith recommend this product.

1.7

Patient Review

10/31/2022

Climara Pro for "Change of Life" Signs

The side effects of this medication were extremely unpleasant. I experienced hot, swollen hands and feet; headaches; weight gain; vaginal discharge; heart palpitations; breathlessness; itchy calves; total loss of libido; food cravings; blurred vision; and cramping. I was very glad to be done with the treatment after just four days.

1

Patient Review

8/14/2019

Climara Pro for "Change of Life" Signs

The Climara Pro patch was a terrible experience for me. After just three days, the patch started coming off. By day four, it was almost completely gone and formed cone-shaped openings. I would not recommend this patch to anyone.

1

Patient Review

6/1/2020

Climara Pro for "Change of Life" Signs

This patch is ridiculously expensive and it doesn't even stay on.

1

Patient Review

3/27/2020

Climara Pro for "Change of Life" Signs

I found this patch to be ineffective as it did not stay on for the entire week. I would suggest that the manufacturers consider making a daily patch.

1

Patient Review

10/17/2022

Climara Pro for "Change of Life" Signs

This patch is terrible. It's cheaply made, falls off constantly, and is a general waste of money. Do not bother buying this product.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about climara pro

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How long does it take for Climara Pro patch to work?

"I was prescribed Climara Pro and within four days, all my anxiety, hot flashes, and depression disappeared! It was like magic. Sometimes I have spotting or bleeding for a few days, but I'm happy to deal with that."

Answered by AI

What is Climara Pro used for?

"Climara Pro is a medication that contains both an estrogen and a progestogen. It is used to reduce hot flashes and help prevent osteoporosis in postmenopausal women who have a uterus."

Answered by AI

What are the side effects of Climara?

"You may experience skin redness or irritation, abdominal pain, nausea or vomiting, bloating, breast tenderness, headache, or weight changes when taking this medication. If you experience any of these symptoms, speak to your doctor or pharmacist."

Answered by AI

What is the difference between Climara and Climara Pro?

"Climara Pro and Climara are both skin patches. Climara Pro is applied once a week and Climara is applied once or twice a week."

Answered by AI

Clinical Trials for Climara Pro

Image of VA Greater Los Angeles Healthcare System, West Los Angeles, CA in West Los Angeles, United States.

EBQI Strategies for Women's Health

Any Age
All Sexes
West Los Angeles, CA

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Waitlist Available
Has No Placebo

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Alison B Hamilton, PhD MPH

Image of Lindus Health - DECENTRALIZED STUDY in Boston, United States.

Neurostimulation for Heavy Menstrual Bleeding

14 - 45
Female
Boston, MA

The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria). During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort. During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.

Waitlist Available
New This Month

Lindus Health - DECENTRALIZED STUDY

Navid Khodaparast, PhD

Spark Biomedical, Inc.

Image of Erevna Innovations Inc. in Montreal, Canada.

Sculptra + Restylane for Post-Menopausal Skin Concerns

40 - 65
Female
Montreal, Canada

The post-menopausal state is marked by a sharp decline in estrogen, leading to significant structural and functional changes in the skin, including collagen loss, dryness, thinning, and reduced elasticity. To address these concerns, aesthetic injectables products such as Sculptra® Aesthetic (poly-L-lactic-acid \[PLLA- SCA\]) and Restylane Skinboosters®\[HASBV\] (small-particle hyaluronic acid - SP-HA) can be used. PLLA-SCA stimulates collagen production via cellular activation (biostimulator), gradually improving dermal structure. HASBV enhances hydration, elasticity, and skin texture when injected under the skin. Considering that hydration and laxity represent the primary aesthetic concerns in this patient population. Targeted treatment with SP-HA (HASBV) to improve hydration and PLLA-SCA to address laxity have been shown to produce significant clinical outcomes by directly addressing these key dermal deficiencies. This approach forms the basis of the current study.

Phase 4
Recruiting

Erevna Innovations Inc.

Andreas Nikolis, MD, PhD

Image of University Hospitals Cleveland Medical Center in Cleveland, United States.

Ketamine for Pelvic Pain

18 - 89
Female
Cleveland, OH

The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.

Phase 4
Waitlist Available

University Hospitals Cleveland Medical Center

Morgan Cheeks, MD

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We made a collection of clinical trials featuring Climara Pro, we think they might fit your search criteria.
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Image of William J. Hybl Sports Medicine and Performance Center in Colorado Springs, United States.

Moderate Aerobic Exercise for Menstrual Symptoms

18 - 40
Female
Colorado Springs, CO

The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.

Recruiting
Has No Placebo

William J. Hybl Sports Medicine and Performance Center

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We made a collection of clinical trials featuring Climara Pro, we think they might fit your search criteria.
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Image of Alethios, Inc. in San Francisco, United States.

NettleEndo for Endometriosis

22 - 45
Female
San Francisco, CA

The goal of this clinical trial is to learn if a wearable brain stimulation device called NettleEndo can reduce chronic pelvic pain and improve wellbeing in women with endometriosis. The study also aims to assess the safety and usability of the device when used at home over several months. The main questions it aims to answer are: 1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality? Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms. Participants will: 1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Be followed for 90 days after completing the intervention to monitor longer-term effects All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.

Recruiting
Online Trial

Alethios, Inc.

Nirav Shah, MD, MPH

Samphire Group, Inc.

Image of University of Alabama at Birmingham in Birmingham, United States.

Mirena for Endometrial Hyperplasia

18+
Female
Birmingham, AL

Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH). Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer. Currently, there are no approved treatments for NAEH and that is why there is still an unmet medical need. The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone. In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body. The main purpose of this study is to show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population. For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA. The study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months. Each participant will be in the study for around 10 months with up to 5 visits to the study clinic/site. Participants will visit the study clinic: * once before the treatment starts * 3 times with a gap of 3 months between the visits during the treatment * then 1 more time after the treatment ends During the study, the doctors and their study team will: * check participant's health by performing tests such as blood and urine tests * perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time. * take samples of womb (endometrial) lining * ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Phase 3
Recruiting

University of Alabama at Birmingham (+81 Sites)

Bayer

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We made a collection of clinical trials featuring Climara Pro, we think they might fit your search criteria.
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