What side effects are associated with this type of intervention?

Common side effects of hormonal birth control methods, including injectable forms like Levonorgestrel Butanoate (LB), can include irregular bleeding, mood changes, and potential thromboembolic events. Injectable contraceptives may also cause weight gain, headaches, and breast tenderness. Progestin-only pills, such as those containing levonorgestrel, can lead to unscheduled bleeding and mood alterations. It is important to discuss these potential side effects with a healthcare provider to determine the most suitable contraceptive method.

What prior FDA approvals exist?

The FDA has approved various forms of birth control, including oral contraceptives and injectables. Notably, levonorgestrel is a common progestin used in both oral and injectable forms. Oral contraceptives like Alesse, which combines levonorgestrel with ethinyl estradiol, have been approved and shown to be effective with a Pearl index of 0.84. Injectable forms, such as Depo-Provera (medroxyprogesterone acetate), provide long-term contraception through intramuscular administration. These treatments focus on inhibiting ovulation, thickening cervical mucus, and altering the endometrium to prevent pregnancy. The ongoing study of injectable levonorgestrel butanoate (LB) aims to further explore the pharmacokinetics and pharmacodynamics of this progestin for female contraception.

What other types of research exist?

Promising novel alternatives to Injectable LB for birth control in 2024 include: 1) Ornibel® contraceptive vaginal ring, which has shown bioequivalence and safety compared to Nuvaring®; 2) Continuous combined oral contraceptives (COCs) with levonorgestrel/ethinyl estradiol, which have shown efficacy in reducing PMS and PMDD symptoms; 3) Levonorgestrel-releasing intrauterine devices (LNG-IUDs), which are effective for long-term contraception and management of endometriosis symptoms.

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Progestin

LB Injection for Birth Control

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met

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.