Quartette

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Quartette

What is Quartette

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (LNG) is a hormone that is used for contraception and hormone therapy. It is often referred to as Plan B and is used in emergency contraception pills and intrauterine devices (IUDs) like Jaydess, Kyleena, and Mirena. It can also be used as part of a long-term combination contraceptive. The FDA approved levonorgestrel in 1982, making it the first emergency contraceptive with only progesterone. It has been found to be highly effective and not associated with estrogenic side effects.

Triphasil-21

is the brand name

image of different drug pills on a surface

Quartette 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 Quartette Affects Patients

Levonorgestrel is a hormone used as an emergency contraceptive pill to prevent pregnancy. It is 89% effective if taken within 72 hours after intercourse. The intrauterine and implantable devices containing levonorgestrel are over 99% effective. Additionally, levonorgestrel helps to prevent endometrial cancer when taken as part of a hormonal therapy program.

How Quartette works in the body

Levonorgestrel is a hormone that works to prevent pregnancy in multiple ways. It works by suppressing the release of gonadotropin-releasing hormone, which prevents the normal physiological luteinizing hormone surge that leads to ovulation. It also thickens cervical mucus, making it hard for sperm to enter and survive in the uterus. Finally, when combined with estrogen, levonorgestrel can lower the risk of endometrial cancer by inhibiting endometrial proliferation.

When to interrupt dosage

The preferred measure of Quartette is subject to the determined condition, for example Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The quantity of dosage is contingent upon the method 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, 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, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous

Warnings

Quartette 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 Quartette.

Common Quartette 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.

Quartette Toxicity & Overdose Risk

The lowest toxic dose of levonorgestrel in rats has been determined to be greater than 5000mg/kg. Those who overdose on levonorgestrel may experience nausea and bleeding. Treatment should focus on relieving symptoms and contacting a poison control center. There is no known antidote for levonorgestrel overdose.

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

99 active trials are being conducted to explore the potential of Quartette in treating Postmenopausal Osteoporosis, Mothers Who Have Had at least 1 Child 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

Quartette Reviews: What are patients saying about Quartette?

5

Patient Review

8/12/2016

Quartette for Birth Control

I've been on this treatment for 2.5 years now, and I can say that it's been incredibly effective. The first pack of pills wasn't perfect, but after a few months my periods shortened, cramps became tolerable, and acne was at a minimum. My sex drive was unaffected. The first period I had with this medication was awful, but subsequent ones have been better and better.

4.7

Patient Review

6/8/2015

Quartette for Birth Control

I've been using Quartette for a year now, and I'm very happy with it. The first few months were a bit tough with constant spotting, but my doctor assured me that it was normal. I haven't had any major problems since then, just the occasional spot of light bleeding or cramp here and there.

4.7

Patient Review

11/11/2015

Quartette for Painful Periods

I had no issues with this drug whatsoever. I actually lost weight while taking it- about 30 pounds. My periods are now more regular, and only one in three is as painful as before.

4.7

Patient Review

7/8/2016

Quartette for Endometriosis

I only experience pain during my period, which is a marked improvement. However, I've been getting more yeast infections and acne. Overall, it does what it's supposed to do-- giving me four periods a year-- but the side effects are unfortunate.

4

Patient Review

6/14/2015

Quartette for Endometriosis

This treatment has been working well for me so far. I haven't had any major issues, just some mild cramping and occasional headaches.

4

Patient Review

8/3/2017

Quartette for Birth Control

I started this pill a month and a half ago and it's been great. I haven't spotted or gotten any acne, but I have been very depressed since starting. I just looked up side effects today and remembered that I changed birth control around the same time, so I will be stopping. I think this may only be an issue for someone who's been depressed before. Otherwise it was great.

3

Patient Review

7/14/2015

Quartette for Birth Control

I found this treatment really inconvenient and uncomfortable. I was constantly bleeding, which was both painful and embarrassing. I also experienced a lot of cramping, bloating, and back acne. Overall, not a great experience.

2

Patient Review

7/12/2015

Quartette for Abnormally Long or Heavy Periods

I was prescribed this by my gyn for heavy bleeding. I took quartette for 14 months. As a result, I got an incredibly severe headache that required transport to two different hospitals. Now I have blood clots in my brain and have to take blood thinners to prevent more from forming. This medication is incredibly dangerous and should be avoided at all cost.

Patient Q&A Section about quartette

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

When should I get my period on the pill?

"On average, women will start their period three days after taking the last active pill in a 28-pill pack. If you are using a 28-pill pack, you will get your period during the week that you take the hormone-free pills."

Answered by AI

What happens if you take birth control pills while pregnant?

"If you take birth control pills while you are pregnant, don't worry. Despite years of this accident happening, there's very little evidence that exposure to the hormones in birth control pills causes birth defects."

Answered by AI

What is Quartette?

"Quartets are typically formed in classical music settings, though they exist in other genres, as well.

A group of four singers or instrumentalists is called a quartet, or a musical composition for four voices or instruments is called a quartet. Quartets are typically formed in classical music settings, but they can exist in other genres as well."

Answered by AI

What is in Yaz birth control?

"This medication is a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). This product is taken once daily, by mouth, with or without food."

Answered by AI

Clinical Trials for Quartette

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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