Levonorgestrel

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

What is Levonorgestrel

LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel (LNG) is a synthetic hormone similar to progesterone used in contraception, hormone therapy, and emergency contraception. It is available as Plan B for emergency contraception, as an intrauterine device (IUD) such as Jaydess, Kyleena, and Mirena, and as a subdermal implant that slowly releases the hormone over time. Levonorgestrel is also used as a component of long-term combination contraceptives. It was first approved by the FDA in 1982 and is the most commonly used emergency contraceptive due to its high levels of efficacy and lack of estrogenic side effects.
Triphasil-21is the brand name
image of different drug pills on a surface
Levonorgestrel 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
Has had at least 1 child
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
Emergency Contraception
Hot flashes
Used to treat Menopause in combination with Estradiol

Effectiveness

How Levonorgestrel Affects PatientsLevonorgestrel is a type of contraceptive that prevents pregnancy by blocking ovulation, fertilization, and implantation. When taken as an emergency contraceptive pill, it is 89% effective if taken within 72 hours after sex. When used in intrauterine or implantable devices, it is more than 99% effective in preventing pregnancy. Additionally, levonorgestrel can be used as part of hormonal therapy to reduce the risk of endometrial cancer caused by taking estrogen alone.
How Levonorgestrel works in the bodyLevonorgestrel is used in oral contraceptives to prevent ovulation. It works by reducing the release of hormones from the hypothalamus, which prevents the release of an egg from the ovaries. It also makes cervical mucus thicker, which stops or slows sperm from reaching the egg. Over a long-term period, levonorgestrel has been proven to thicken cervical mucus. When combined with estrogen for menopausal symptoms, it helps to lower the risk of endometrial cancer. The exact mechanism of action is not fully understood, but it is believed that it affects the movement and survival of sperm and alters

When to interrupt dosage

The recommended measure of Levonorgestrel is contingent upon the identified condition, such as Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage changes in accordance with the technique of delivery featured in the table beneath.
Condition
Dosage
Administration
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
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
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
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
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
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
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

Warnings

Levonorgestrel Contraindications
Condition
Risk Level
Notes
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
Severe Hypersensitivity Reactions
Do Not Combine
Levonorgestrel may interact with Pulse Frequency
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.
Common Levonorgestrel 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 Toxicity & Overdose RiskThe lowest toxic dose of levonorgestrel for rats is greater than 5000 mg/kg. If someone overdoses on this drug, they may experience nausea and bleeding. Treat the symptoms and contact a poison control center as soon as possible. There is no known cure for this type of overdose.
image of a doctor in a lab doing drug, clinical research

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

Presently, 99 clinical trials are underway to assess the efficacy of Levonorgestrel in managing Postmenopausal Osteoporosis, Women who have had at least 1 child and Endometrial Hyperplasia.
Condition
Clinical Trials
Trial Phases
Endometriosis
28 Actively Recruiting
Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4
Hot flashes
21 Actively Recruiting
Phase 1, 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 Reviews: What are patients saying about Levonorgestrel?

4.7Patient Review
8/17/2013
Levonorgestrel for Postcoital Contraception
I experienced some nausea after taking this medication, but it was still effective. Make sure you take the oral medication within 72 hours for best results. Different women will have different experiences, so make sure to read the side effects before taking the medication.
4.7Patient Review
12/27/2010
Levonorgestrel for Postcoital Contraception
I started my period about a week after taking this drug, and I had no side effects.
4.3Patient Review
12/13/2009
Levonorgestrel for Postcoital Contraception
I took Plan B and, though I felt a little nauseous, my period came right on time. Thank goodness!
4Patient Review
4/25/2017
Levonorgestrel for Postcoital Contraception
I was on this pill for eight years. It did what it was supposed to do, but I started getting severe headaches and experiencing wild mood swings and cravings before my period. I understand that our bodies change a lot over time, so that may be why this happened to me. In any case, I had to switch pills eventually.
3.7Patient Review
8/17/2009
Levonorgestrel for Postcoital Contraception
I tried to take this medication twice a month, and it would often advance my period by 10-15 days.
1Patient Review
8/31/2021
Levonorgestrel for Postcoital Contraception
I took this medication a few hours after unprotected sex and then began bleeding from my vagina five days later. This lasted for three days, but I have yet to see my period (it was supposed to come on August 19th). The laboratory said I couldn't be pregnant, but I'm not sure what else could be the problem. Note: I took two pills at once for two days.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about levonorgestrel

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

How long does levonorgestrel take to work?

"The drug is effective at preventing pregnancy if taken within 72 hours of unprotected sex. However, it is not effective as a regular method of contraception and will not always stop a pregnancy. It should not replace regular, long-term contraception."

Answered by AI

What kind of birth control is levonorgestrel?

"The combination of levonorgestrel and ethinyl estradiol is used to prevent pregnancy by stopping a woman's egg from fully developing each month. This prevents the egg from being able to accept a sperm, and therefore fertilization and pregnancy cannot occur."

Answered by AI

What is levonorgestrel used for?

"The morning-after pill, or emergency contraception, is used to prevent pregnancy after unprotected sex. It can also be used after a birth control method has failed, to prevent pregnancy. It works by stopping a woman's egg from fully developing, or by preventing the egg from attaching to the wall of the uterus."

Answered by AI

What does levonorgestrel do to your period?

"Levonorgestrel, which is found in birth control pills, can alter your body's natural hormone levels if taken in a higher dose as found in Plan B. This can then affect the menstrual cycle, causing an earlier or delayed period, as well as heavier or lighter bleeding."

Answered by AI

Clinical Trials for Levonorgestrel

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 clinical trials? We made a collection of clinical trials featuring Levonorgestrel, 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 clinical trials? We made a collection of clinical trials featuring Levonorgestrel, we think they might fit your search criteria.Go to Trials
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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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