Levonorgestrel And Ethinyl Estradiol

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more
Treatment
7 FDA approvals
20 Active Studies for Levonorgestrel And Ethinyl Estradiol

What is Levonorgestrel And Ethinyl Estradiol

LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel (LNG) is a hormone used in contraception and hormone therapy. It is commonly known as Plan B and is used as an emergency contraceptive pill and in IUDs like Jaydess, Kyleena and Mirena. Levonorgestrel can also be implanted under the skin to slowly release the hormone over time. It is the most widely used emergency contraceptive and was approved by the FDA in 1982. It works more effectively and has fewer side effects than older emergency contraceptives due to its lack of estrogen.
Triphasil-21is the brand name
image of different drug pills on a surface
Levonorgestrel And Ethinyl Estradiol 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 Postmenopausal Osteoporosis and moderate Menopausal Vasomotor Symptoms .
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
Menopause
Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol
Osteoporosis, Postmenopausal
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
Emergency Contraception
Hot flashes
Used to treat Menopause in combination with Estradiol

Effectiveness

How Levonorgestrel And Ethinyl Estradiol Affects PatientsLevonorgestrel is a medication that can prevent pregnancy by preventing ovulation, fertilization, and implantation. It is most effective when taken within 72 hours after intercourse, giving it an 89% success rate. When used in combination with the intrauterine or implantable devices, it is more than 99% effective. Levonorgestrel can also be used as part of hormonal therapy to help prevent endometrial cancer caused by estrogen.
How Levonorgestrel And Ethinyl Estradiol works in the bodyLevonorgestrel works in a few ways to prevent pregnancy. It reduces the release of hormones from the hypothalamus that control ovulation, which stops eggs from being released from the ovaries. It also thickens cervical mucus, making it harder for sperm to enter the uterus and fertilize an egg. Levonorgestrel may also make it harder for eggs to attach to the uterus, making implantation less likely. When taken with estrogen, levonorgestrel helps reduce the risk of endometrial cancer.

When to interrupt dosage

The prescribed dosage of Levonorgestrel And Ethinyl Estradiol is contingent upon the ascertained condition, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage may differ as per the technique of delivery featured in the table below.
Condition
Dosage
Administration
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral

Warnings

Levonorgestrel And Ethinyl Estradiol has forty-three contraindications, thus it should not be taken in combination with any of the conditions listed in the table below.Levonorgestrel And Ethinyl Estradiol 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 Levonorgestrel And Ethinyl Estradiol.
Common Levonorgestrel And Ethinyl Estradiol 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.
Levonorgestrel And Ethinyl Estradiol Toxicity & Overdose RiskThe lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000mg/kg. Symptoms of an overdose on this drug may include nausea and bleeding. If someone experiences an overdose, they should seek treatment for their symptoms and contact their local poison control center. There is no specific antidote for a levonorgestrel overdose.
image of a doctor in a lab doing drug, clinical research

Levonorgestrel And Ethinyl Estradiol Novel Uses: Which Conditions Have a Clinical Trial Featuring Levonorgestrel And Ethinyl Estradiol?

99 active clinical trials are currently assessing the potential of Levonorgestrel And Ethinyl Estradiol in providing relief from Postmenopausal Osteoporosis, Postpartum Status and Endometrial Hyperplasia.
Condition
Clinical Trials
Trial Phases
Endometriosis
27 Actively Recruiting
Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4
Hot flashes
19 Actively Recruiting
Not Applicable, Phase 4, Phase 2, Early Phase 1, Phase 3
Has had at least 1 child
0 Actively Recruiting
Menorrhagia
3 Actively Recruiting
Phase 1, Phase 2, Not Applicable
Endometrial Hyperplasia
4 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

Levonorgestrel And Ethinyl Estradiol Reviews: What are patients saying about Levonorgestrel And Ethinyl Estradiol?

5Patient Review
2/18/2021
Levonorgestrel And Ethinyl Estradiol for Birth Control
I've been on this pill for 3/4 years, and it's been a revelation. I used to get the depo shot, which was fine for a while, but after my first child I started having really bad mood swings around my cycle. The pill has helped regulate that so that now I only have a light bleed every 13 weeks or so.
5Patient Review
7/9/2021
Levonorgestrel And Ethinyl Estradiol for Abnormally Long or Heavy Periods
I've been on a lot of different pills, and this is by far the best one. It's shortened my periods from 9 days to just 5-6, and I haven't had any negative mood changes or side effects like cystic acne.
5Patient Review
12/15/2021
Levonorgestrel And Ethinyl Estradiol for Painful Periods
This birth control completely stopped my monthly period cramps.
5Patient Review
5/31/2021
Levonorgestrel And Ethinyl Estradiol for Birth Control
This drug has been a life saver for me. It not only helped with my period, but it also got rid of the infection I had. And on top of that, it's also great for birth control.
4.7Patient Review
7/19/2022
Levonorgestrel And Ethinyl Estradiol for Abnormally Long or Heavy Periods
My doctor prescribed this to me for peri-menopause and I've been taking it without issue. It's been more effective than other birth control pills I've tried in the past, with no negative mood changes or breakthrough bleeding. The only downside is that it hasn't helped clear my hormonal acne, but the alternative pill my doctor suggested has terrible side effects.
3.7Patient Review
5/1/2022
Levonorgestrel And Ethinyl Estradiol for Birth Control
I took this pill to prevent intense mood swings in between irregular periods. While I was on it, I was convinced my sense of smell changed. For example, I thought my body odor changed! Anyway, it also gave me severe headaches that wouldn't go away. It got so bad, I just quit taking them
3.7Patient Review
8/7/2021
Levonorgestrel And Ethinyl Estradiol for Birth Control
This medicine definitely helps with fertility, but it can also make you very depressed. I have to start looking for something new.
3.7Patient Review
7/11/2022
Levonorgestrel And Ethinyl Estradiol for Absence of Menstrual Periods
I started taking this not too long ago but it made me SO moody. I get so angry and impatient. I don’t know how well this will work out but the pills are really good with my acne and they’re small so you don’t need to take them with a drink.
2.7Patient Review
1/29/2022
Levonorgestrel And Ethinyl Estradiol for Birth Control
I started this medication recently and have been experiencing more cramping than usual. I'm also not seeing as much discharge, which is concerning given that this is my first time using birth control. This pill has me feeling really anxious about what's happening to my body.
1Patient Review
5/5/2021
Levonorgestrel And Ethinyl Estradiol for Birth Control
I started having panic attacks after I got this medication from the pharmacy. In addition to the attacks, I also experience headaches, dizziness, and nausea. This is by far the worst birth control I've ever taken, and I've been on it for two years.
1Patient Review
8/9/2022
Levonorgestrel And Ethinyl Estradiol for Abnormally Long or Heavy Periods
This birth control made me feel depressed, anxious, and constantly afraid. I also had really bad headaches every day. The only good thing about it was that it helped my period to stop.

Patient Q&A Section about levonorgestrel and ethinyl estradiol

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

How long does it take for levonorgestrel and ethinyl estradiol tablets to work?

"You will need to use a second form of birth control for the first week you take this medication, as it takes your body that long to adjust to the medicine. Be sure to take the medication at the same time each day."

Answered by AI

Do you get your period on levonorgestrel and ethinyl estradiol?

"The expected result of taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is to have four scheduled periods per year. Each period is likely to last about two to three days."

Answered by AI

What are the side effect to levonorgestrel and ethinyl estradiol?

"The following side effects may occur while taking this medication: nausea, vomiting, headache, abdominal cramps/bloating, breast tenderness, swelling of the ankles/feet (retaining fluid), or weight change. If you experience any of these side effects, speak to your doctor or pharmacist. It is common for women to not have regular periods while taking this medication."

Answered by AI

Does levonorgestrel cause weight gain?

"A few other possible side effects from using the levonorgestrel system have been weight gain, depression, acne, and some people have also anecdotally reported losing a lot of hair from using it."

Answered by AI

Clinical Trials for Levonorgestrel And Ethinyl Estradiol

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 CenterAdi Cosic, DO
Have you considered Levonorgestrel And Ethinyl Estradiol clinical trials? We made a collection of clinical trials featuring Levonorgestrel And Ethinyl Estradiol, we think they might fit your search criteria.Go to Trials
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
Have you considered Levonorgestrel And Ethinyl Estradiol clinical trials? We made a collection of clinical trials featuring Levonorgestrel And Ethinyl Estradiol, we think they might fit your search criteria.Go to Trials
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. Wear an optional fitness tracker to collect data on sleep, movement, and heart rate variability 5. Be followed for 60 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, MPHSamphire 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
Waitlist Available
University of Alabama at Birmingham (+75 Sites)Bayer
Image of Baylor College of Medicine in Hosuton, United States.

Dronabinol for Endometriosis

18 - 64
Female
Hosuton, TX
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
Phase 2
Waitlist Available
Baylor College of Medicine (+1 Sites)Christopher Verrico, PhD in Pharmacology
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