Quasense

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Quasense

What is Quasense

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (LNG) is a type of synthetic hormone used in contraception and hormone therapy. It is also known as ‘Plan B’ and is used as an emergency contraceptive pill or as a hormone released from an intrauterine device (IUD). Other long-term devices containing levonorgestrel are also available, such as Jaydess, Kyleena and Mirena. Levonorgestrel is the most widely used emergency contraceptive pill and was approved by the FDA in 1982. It is highly effective and has fewer side effects than other emergency contraceptives due to its lack of estrogen.

Triphasil-21

is the brand name

image of different drug pills on a surface

Quasense 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 Quasense Affects Patients

Levonorgestrel is a form of contraception that prevents pregnancy by blocking ovulation, fertilization, and implantation. If taken in the form of an emergency contraceptive pill within 72 hours after intercourse, it is 89% effective. When used as an intrauterine or implantable device, it is over 99% effective. Additionally, it can be used as a form of hormone therapy to help prevent cancer in the uterus.

How Quasense works in the body

Levonorgestrel is a hormone used in contraceptives and hormone therapy. To prevent ovulation, it binds to progesterone and androgen receptors and slows the release of a hormone from the brain that triggers ovulation. It also thickens cervical mucus, which makes it harder for sperm to move and survive, and may also change the endometrium, making it harder for a fertilized egg to implant. Finally, when used in combination with estrogen, levonorgestrel works to reduce the risk of endometrial cancer.

When to interrupt dosage

The prescribed amount of Quasense is contingent upon the verified affliction, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The measure of dosage is dictated by the technique of delivery outlined 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, Patch, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous

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

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

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

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

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

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

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

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

Warnings

Quasense has forty-three contraindications, hence it should not be consumed while enduring any of the conditions specified in the following table.

Quasense 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 Quasense.

Common Quasense 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.

Quasense Toxicity & Overdose Risk

The lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000 mg/kg. An overdose of this drug may cause nausea and bleeding similar to a menstrual period. If someone overdoses, they should be provided with supportive care and the local poison control center should be contacted. There is no known antidote for a levonorgestrel overdose.

Quasense Novel Uses: Which Conditions Have a Clinical Trial Featuring Quasense?

99 active investigations are being conducted to assess the potential of Quasense to treat Postmenopausal Osteoporosis, Post-Partum Women and Endometrial Hyperplasia.

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

Quasense Reviews: What are patients saying about Quasense?

5

Patient Review

9/20/2013

Quasense for Birth Control

I've been using this birth control for years with no problems. It's also the only one that ever helped with my morning sickness. I highly recommend it.

4.7

Patient Review

12/24/2017

Quasense for Birth Control

Quasense has been an amazing addition to my life for the past three months. It's helped with my acne, period pains, and flow-- all without any negative side effects like spotting or weight gain. I would highly recommend this birth control to anyone seeking a low-maintenance but effective solution.

4

Patient Review

8/11/2013

Quasense for Birth Control

I've been using this medication for four months now with mostly good results. My period symptoms have lightened, and I haven't experienced any extreme side effects; though I have put on some weight since starting the drug. The only downside is that it can be difficult to remember to take it at the same time every day.

3.3

Patient Review

2/10/2018

Quasense for Birth Control

Quasense has been my pill for about a year now, and I'm ready to move on. The weight gain and difficulty losing it, the acne, bloating, mood swings, and increased monthly spotting have all been frustrating side effects of this medication.

3

Patient Review

10/10/2013

Quasense for Birth Control

I've only been taking this pill for a week, but I have noticed some side effects like dizziness and numbness in my tongue. So far it's okay, but I take it at night so I don't have to deal with the headache during the day. My biggest worry was weight gain, but thankfully I haven't had any issues there.

3

Patient Review

1/2/2014

Quasense for Birth Control

I didn't like this because I got headaches almost every day. My libido decreased, and I felt terrible all the time. Additionally, my skin would clear up and then break out again the very next day.

2

Patient Review

4/12/2014

Quasense for Birth Control

I tried this for a month and was very disappointed. I had to leave school early the first day due to nausea and vomiting. My face also broke out more than it ever has while taking Quasense. Additionally, I don't gain weight easily, but I gained six pounds in one month while taking this medication. Overall, not recommended.

1

Patient Review

7/26/2016

Quasense for Birth Control

I gained a lot of weight, started bleeding constantly, and my depression got worse. I also developed chest and back acne, as well as weird bumps on my arms. Do not take this medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about quasense

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

What is the generic for seasonique?

"is indicated for use by females of reproductive potential to prevent pregnancy.

SIMPESSE is indicated for use by females of reproductive potential for the prevention of pregnancy."

Answered by AI

What is seasonique prescribed for?

"Seasonique is a contraceptive pill that is taken once a week. It contains a lower dose of hormones than other birth control pills and also helps to regulate your periods. Seasonique may be used alone or with other medications. It is not known if Seasonique is safe and effective in children before menarche."

Answered by AI

What is Quasense generic for?

"QUASENSE (levonorgestrel and ethinyl estradiol) is an extended-cycle combination oral contraceptive that consists of 84 white active tablets (each containing 0.15 mg of levonorgestrel—a synthetic progestin—and 0.03 mg of ethinyl estradiol) and 7 peach inert tablets (without hormones)."

Answered by AI

Is Quasense discontinued?

"The Quasense brand name is no longer available in the United States. If the FDA has approved generic versions of this product, there may be generic equivalents available."

Answered by AI

Clinical Trials for Quasense

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

Erin P Finley, 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
Online Trial

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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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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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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