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Progestin

LB Injection for Birth Control

Phase 1
Recruiting
Research Sponsored by Health Decisions
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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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.

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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

Levonorgestrel Butanoate (LB) Injection (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT04143659 — Phase 1
Birth Control Research Study Groups: LB injection 40 mg subcutaneous (SQ) with 70 mg/ml concentration, LB injection 40 mg subcutaneous (SC) with 20 mg/ml concentration, LB injection 50mg subcutaneous (SQ) with 70 mg/ml concentration, LB injection 60mg Subcutaneous (SQ) with 70 mg/ml concentration, LB injection 40mg intramuscular (IM) with 20 mg/ml concentration
Birth Control Clinical Trial 2023: Levonorgestrel Butanoate (LB) Injection Highlights & Side Effects. Trial Name: NCT04143659 — Phase 1
Levonorgestrel Butanoate (LB) Injection (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04143659 — Phase 1
~24 spots leftby Oct 2025