LB Injection for Birth Control

Not currently recruiting at 6 trial locations

Overseen By Carly Shabshelowitz

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Health Decisions

Must not be taking: Hormonal contraceptives, Anticoagulants, Antibiotics, others

Disqualifiers: Alcohol dependence, Breastfeeding, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new injectable birth control method using the hormone Levonorgestrel Butanoate (LB). The goal is to determine the safest and most effective dose for preventing pregnancy. Participants will receive different doses to observe how the body processes the hormone. Suitable candidates are women in good health who have regular menstrual cycles and are not currently using hormonal contraception. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new method.

Do I have to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants who use medications that interfere with hormonal contraceptives or are on the Exclusionary Medication List. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that levonorgestrel, the main ingredient in the LB injection being tested, has been safely used in birth control pills since the 1960s. This long history suggests it is generally safe for people.

Studies on levonorgestrel butanoate, the injectable form, have examined its effectiveness and side effects. Available data indicate that different doses have been tested, and researchers are studying its duration and effects. Although detailed safety information for the injectable form is still being collected, its similarity to the well-known pill form offers some reassurance about its safety.

As this is an early-phase study, the main goal is to understand how the drug works in the body and assess its initial safety. Researchers are beginning to observe how people handle the injections. While some side effects might be identified, more research is needed to fully understand its safety for a broader population. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Levonorgestrel Butanoate (LB) injections for birth control because they offer a potentially more convenient and longer-lasting alternative to current options like daily pills or monthly injections. Unlike traditional hormonal contraceptives, the LB injection is administered subcutaneously or intramuscularly, allowing for the possibility of less frequent dosing while maintaining effective contraceptive action. The use of different concentrations and dosages in the trial also aims to identify the most efficient formulation for diverse body types, potentially offering more personalized birth control options. This could lead to more accessible and user-friendly contraception, reducing the risk of missed doses and improving overall efficacy.

What evidence suggests that this trial's treatments could be effective for birth control?

This trial will evaluate various doses and concentrations of Levonorgestrel Butanoate (LB) injections as a form of birth control. Studies have shown that LB injections can be effective, with research indicating that different doses work for varying lengths of time. For instance, a 50 mg dose can prevent ovulation for up to 265 days in some women. However, previous findings suggest that LB may not consistently stop ovulation for 90 days in all women, particularly those with a higher Body Mass Index (BMI). Overall, while promising, the effectiveness depends on the dose and individual factors like body weight. ^{1 2 3 6 7}

Who Is on the Research Team?

Diana Blithe

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of levonorgestrel butanoate (LB) via IM or SQ injection, with dose adjustments based on PK/PD results

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness until return to ovulation and normal menses, with frequent evaluations and serum sampling

12-26 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Levonorgestrel Butanoate (LB) Injection

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.

How Is the Trial Designed?

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+

Premier Research

Lead Sponsor

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5140699/

Levonorgestrel butanoate intramuscular injection does not ... Levonorgestrel butanoate intramuscular injection does not reliably suppress ovulation for 90 days in obese and normal BMI women: a pilot study · Alison B Edelman ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07222228

A Study to Evaluate the Efficacy and Safety of ... The primary aim of the study is to evaluate the contraceptive efficacy of LB SQ injections over 8 cycles. ... Levonorgestrel Butanoate for Female ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04143659

A Study to Evaluate the PK and PD of IM or SQ Injections ... This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, ...

4. reporter.nih.gov reporter.nih.gov/project-details/8261608

clinical evaluation of levonorgestrel butanoate for female ... The objective of the dose- finding is to identify a dose that can provide reliable contraception for 4 months in non-obese and in obese women. To evaluate ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S001078241630172X

Levonorgestrel butanoate intramuscular injection does not ... These studies showed a clear dose response and the duration of action based on return to ovulation (12.5 mg=105 days, 25 mg=231 days, 50 mg=265 days [2], [3] ...

6. techtransfer.nih.gov techtransfer.nih.gov/tech/tab-4435

Levonorgestrel Butanoate Formulation and Methods ... Injectables have lower failure rates than combined hormonal birth control pills or patches or progestin-only pills (POP). ... NICHD developed an ...

7. en.wikipedia.org en.wikipedia.org/wiki/Levonorgestrel_butanoate

Levonorgestrel butanoate The drug has a well-established safety record owing to the use of levonorgestrel as an oral contraceptive since the 1960s. Parenteral potencies and durations of ...