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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 and 40 years inclusive at the injection visit
Intact uterus with at least one ovary
Must not have
Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.
Current or past deep vein thrombophlebitis or thromboembolic disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial tests different doses of a drug called LB, given as injections, in healthy women with normal ovulatory function. It aims to see how the drug affects their menstrual cycles and how it moves through their bodies. Levonorgestrel butanoate (LB) is a new formulation designed to be a long-acting injectable contraceptive.
Who is the study for?
Healthy women aged 18-40 with a BMI under 40, regular menstrual cycles, and no chronic medical conditions. They must not be at risk for pregnancy during the study, have an intact uterus with at least one ovary, and agree to use non-hormonal contraception if sexually active. Exclusions include hypersensitivity to progestins, drug abuse, uncontrolled thyroid disorders, cardiovascular diseases or thrombosis risks.
What is being tested?
The trial is testing Levonorgestrel Butanoate (LB) injections as a method of birth control in healthy women. It's an open-label study where participants receive three different doses (40 mg IM followed by 50mg SQ then potentially increasing to 60 mg SQ), depending on initial results.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, hormonal changes that could affect mood or weight, headaches, nausea or other digestive issues. Since it's a contraceptive trial involving hormones, there might also be changes in menstrual cycle patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
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I have a uterus and at least one ovary.
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My progesterone level is above 3 ng/ml, confirming I ovulate.
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I am generally healthy without chronic conditions needing frequent medical care.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am related or close to someone who works on the study.
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I have had blood clots in my veins.
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I have a history of blood clotting disorders.
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I am HIV positive.
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I need hormone therapy or blood thinners for my condition.
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I have or might have cancer that grows with hormones, like breast or uterine cancer.
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I have unexplained bleeding from my genital area.
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I am a woman planning major surgery while in the study.
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My weight has changed by more than 10% in the last year or I plan to lose a significant amount of weight during the study.
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I am currently using hormonal birth control.
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My thyroid disorder is not under control.
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I have heart or blood vessel disease, or a high risk of blood clots in arteries.
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My liver is not functioning properly, with tests showing high levels.
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I have not been in a drug/device trial in the last 3 months and won't join another during this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
5Treatment groups
Experimental Treatment
Group I: LB injection 60mg Subcutaneous (SQ) with 70 mg/ml concentrationExperimental Treatment1 Intervention
32 subjects (16 with BMI \<30mg\^2; 16 with BMI \>=30kg/m\^2 and \<40kg/m\^2) will be administered a single dose of levonorgestrel butanoate (LB) injection 60mg subcutaneous (SC) using 70 mg/ml concentration
Group II: LB injection 50mg subcutaneous (SQ) with 70 mg/ml concentrationExperimental Treatment1 Intervention
8 subjects (8 with BMI \<40 kg/m2) will be administered a single dose of levonorgestrel butanoate (LB) injection 50mg intramuscular (IM) using 70 mg/ml concentration
Group III: LB injection 40mg intramuscular (IM) with 20 mg/ml concentrationExperimental Treatment1 Intervention
27 subjects (18 with BMI \<30mg\^2; 9 with BMI \>=30kg/m\^2 and \<40kg/m\^2) were administered a single dose of levonorgestrel butanoate (LB) injection 40mg intramuscular (IM) using 20 mg/ml concentration
Group IV: LB injection 40 mg subcutaneous (SQ) with 70 mg/ml concentrationExperimental Treatment1 Intervention
32 subjects (21 with BMI \<30mg\^2; 11 with BMI \>=30kg/m\^2 and \<40kg/m\^2) were administered a single dose of levonorgestrel butanoate (LB) injection 40mg subcutaneous (SC) using 70 mg/ml concentration
Group V: LB injection 40 mg subcutaneous (SC) with 20 mg/ml concentrationExperimental Treatment1 Intervention
32 subjects (25 with BMI \<30mg\^2; 7 with BMI \>=30kg/m\^2 and \<40kg/m\^2) were administered a single dose of levonorgestrel butanoate (LB) injection 40mg subcutaneous (SC) using 20 mg/ml concentration
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common birth control treatments, such as injectable Levonorgestrel Butanoate (LB), work primarily by preventing ovulation, thickening cervical mucus to block sperm entry, and altering the uterine lining to prevent implantation. These mechanisms ensure effective pregnancy prevention and help patients understand the importance of adherence to the treatment regimen and potential interactions with other medications.
Use of progestins.Effects of felbamate on the pharmacokinetics of a low-dose combination oral contraceptive.The problem of medicating women like the men: conceptual discussion of menstrual cycle-dependent psychopharmacology.
Use of progestins.Effects of felbamate on the pharmacokinetics of a low-dose combination oral contraceptive.The problem of medicating women like the men: conceptual discussion of menstrual cycle-dependent psychopharmacology.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Health DecisionsLead Sponsor
30 Previous Clinical Trials
13,866 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,028 Previous Clinical Trials
2,659,894 Total Patients Enrolled
Diana BlitheStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 Previous Clinical Trials
1,105 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent Pap test results meet the required guidelines and no further treatment is needed.I've used long-acting birth control injections in the last 9 months but had at least one normal period since.I am related or close to someone who works on the study.I have had at least 2 menstrual cycles since giving birth or having a second-trimester abortion.I have had blood clots in my veins.I am between 18 and 40 years old.I have had at least one complete menstrual cycle since stopping hormonal birth control.I am not on medications that affect birth control or are unsafe in pregnancy.I have no undiagnosed vaginal issues, or if diagnosed with Chlamydia or gonorrhea, I have completed treatment.I have a history of blood clotting disorders.I am not at risk of becoming pregnant during the study.I am HIV positive.I need hormone therapy or blood thinners for my condition.You are currently using a copper intrauterine device (IUD) for birth control.Your body mass index (BMI) is less than 40 kg/m2.I have a uterus and at least one ovary.I smoke more than 15 cigarettes a day or use more than 1 ml/day of e-cigarette liquid.I am willing to keep a daily diary for the study.My progesterone level is above 3 ng/ml, confirming I ovulate.I have or might have cancer that grows with hormones, like breast or uterine cancer.I have unexplained bleeding from my genital area.I haven't taken any medication from the Exclusionary List in the last 90 days.I am generally healthy without chronic conditions needing frequent medical care.You have a known allergy or medical condition that prevents you from taking progestins.I am a woman planning major surgery while in the study.You have a problem with alcohol or drug addiction that could affect how the study drug works or your ability to follow the study instructions.You are allergic to the main ingredient or other ingredients of the study treatment.I have been cancer-free (except for basal cell carcinoma) for over 5 years.My weight has changed by more than 10% in the last year or I plan to lose a significant amount of weight during the study.I am currently using hormonal birth control.My thyroid disorder is not under control.I have heart or blood vessel disease, or a high risk of blood clots in arteries.My liver is not functioning properly, with tests showing high levels.I have not been in a drug/device trial in the last 3 months and won't join another during this study.
Research Study Groups:
This trial has the following groups:- Group 1: LB injection 40 mg subcutaneous (SQ) with 70 mg/ml concentration
- Group 2: LB injection 40 mg subcutaneous (SC) with 20 mg/ml concentration
- Group 3: LB injection 50mg subcutaneous (SQ) with 70 mg/ml concentration
- Group 4: LB injection 60mg Subcutaneous (SQ) with 70 mg/ml concentration
- Group 5: LB injection 40mg intramuscular (IM) with 20 mg/ml concentration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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