LB Injection for Birth Control

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Health Decisions

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Diana Blithe

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

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.

Inclusion Criteria

My recent Pap test results meet the required guidelines and no further treatment is needed.

I have had at least 2 menstrual cycles since giving birth or having a second-trimester abortion.

Have a negative urine pregnancy test at the injection visit and no unprotected heterosexual intercourse for the previous 10 days

Exclusion Criteria

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.

Have previously participated in the study. A waiver may be requested to allow subjects to re-enroll, but only in a separate stage from the prior enrollment(s). Subjects must have had clear documentation of ovulation based on a rise in progesterone in their previous enrollment

Treatment Details

Interventions

• Levonorgestrel Butanoate (LB) Injection (Progestin)

Trial Overview 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.

Participant Groups

Group I: LB injection 60mg Subcutaneous (SQ) with 70 mg/ml concentration Experimental Treatment 1 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 concentration Experimental Treatment 1 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 concentration Experimental Treatment 1 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 concentration Experimental Treatment 1 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 concentration Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Health Decisions

Lead Sponsor

Trials

31

Recruited

14,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland