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

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (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-21

is 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 Osteoporosis, Postmenopausal and Postmenopausal Osteoporosis .

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis 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

Menopause

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

Emergency Contraception

Hot flashes

Used to treat Menopause in combination with Estradiol

Effectiveness

How Levonorgestrel And Ethinyl Estradiol Affects Patients

Levonorgestrel 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 body

Levonorgestrel 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

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

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 Risk

The 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

Menorrhagia

3 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Has had at least 1 child

0 Actively Recruiting

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?

5

Patient 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.

5

Patient 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.

5

Patient Review

12/15/2021

Levonorgestrel And Ethinyl Estradiol for Painful Periods

This birth control completely stopped my monthly period cramps.

5

Patient 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.

4.7

Patient 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.

3.7

Patient 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

3.7

Patient 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.

3.7

Patient 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.

2.7

Patient 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.

1

Patient 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.

1

Patient 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 Center

Morgan Cheeks, MD

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 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 (+78 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

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