What side effects are associated with this type of intervention?

The most common side effects of male birth control treatments, particularly those involving hormonal regulation like the topical gel combining Nestorone® and testosterone, include skin irritation at the application site, potential changes in libido, mood swings, and alterations in hormone levels. Physical barrier methods, such as condoms, generally have fewer side effects but can cause allergic reactions or discomfort in some users.

What prior FDA approvals exist?

As of now, there are no FDA-approved male birth control methods involving hormonal regulation or topical gels. Current male contraceptive options primarily include physical barriers such as condoms and surgical methods like vasectomy. Research is ongoing in the development of hormonal contraceptives for men, including the combination of Nestorone® (NES) and testosterone (T) gel, which has shown promise in clinical trials for suppressing gonadotropins and potentially serving as a male contraceptive.

What other types of research exist?

Promising novel alternatives to topical gel for male birth control include: 1) Nestorone® and Testosterone combination gel, which is currently under study for its efficacy and safety as a male contraceptive. 2) Biodegradable contraceptive capsules containing levonorgestrel, which have shown potential in preliminary evaluations by suppressing ovulation in women and could be adapted for male use. These methods represent advancements in hormonal regulation for male contraception.

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Hormone Therapy

Male Contraceptive Gel for Birth Control

Phase 2

Waitlist Available

Research Sponsored by Health Decisions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants must be sexually active with a stable, mutually monogamous female partner for at least 1 year prior to screening and have normal reproductive state as demonstrated by specified criteria

Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening

Must not have

Male participants who have participated in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit

Female participants who desire to become pregnant during the study, are breastfeeding, have known or suspected current alcoholism or drug abuse, or are currently pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

This trial is testing a potential male contraceptive gel.

Who is the study for?

This trial is for healthy men aged 18-50, with a BMI under 33, in stable relationships, and not seeking fertility within the next two years. Participants must have normal sperm counts and testosterone levels, no history of hormone treatments in the past six months, and agree to use contraception initially.Check my eligibility

What is being tested?

The study tests a daily gel combining Nestorone® (NES) and Testosterone (T) as a form of male birth control. The goal is to develop an effective contraceptive method for men by applying this gel regularly.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include skin reactions at the application site or hormonal changes such as mood swings or changes in libido due to testosterone alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man in a stable relationship for over a year and have normal reproductive health.

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My recent health checks and lab tests show I am in good health.

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I am a healthy woman aged 18-34, with regular periods, a uterus, and at least one ovary.

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I am a man aged 18-50, with a BMI under 33, and haven't used androgens in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a male who hasn't been in a drug trial in the last 30 days.

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I am not pregnant, breastfeeding, planning to become pregnant, or have a current alcohol or drug abuse issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Contraceptive efficacy provided by the daily application of NES/T gel for 52 weeks during the efficacy phase of the study determined using Kaplan-Meier methods to estimate the 12 month cumulative pregnancy probability in the typical use population.

Secondary outcome measures

Acceptability of NES/T gel as a contraceptive among male and female participants using the acceptability questionnaires.

Changes from baseline in Follicle Stimulating Hormone (FSH) with daily use of the NES/T gel.

Changes from baseline in Luteinizing Hormone (LH) with daily use of the NES/T gel.

+23 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nestorone (NES) + testosterone (T) combined gelExperimental Treatment1 Intervention

A combination Gel with Nestorone® (NES) and Testosterone (T) applied transdermally (NES/T gel). The amount of gel to be applied daily will be approximately 5 mL in volume (2.5 mL to each shoulder and upper arm per day).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nestorone + Testosterone Combination Gel

2017

Completed Phase 1

~20

0 / 6Eligibility 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

The most common treatments for male birth control include hormonal regulation and physical barriers. Hormonal regulation, such as the use of a topical gel combining testosterone and progestin, works by suppressing the production of sperm through the inhibition of gonadotropins, which are hormones necessary for spermatogenesis. This method is significant for male birth control patients as it provides a reversible and non-invasive option. Physical barriers, like condoms, prevent sperm from reaching the egg, offering an immediate and effective method of contraception without hormonal intervention. Both methods are crucial as they provide diverse options catering to different needs and preferences of male birth control patients.

Future directions in contraception.[Non-oral administration of progesterone: experiences and possibilities of the transvaginal route].The problem of medicating women like the men: conceptual discussion of menstrual cycle-dependent psychopharmacology.