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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
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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
I am a man in a stable relationship for over a year and have normal reproductive health.
My recent health checks and lab tests show I am in good health.
I am a healthy woman aged 18-34, with regular periods, a uterus, and at least one ovary.
I am a man aged 18-50, with a BMI under 33, and haven't used androgens in the last 6 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).
First Studied
Drug Approval Stage
How many patients have taken this drug
Nestorone + Testosterone Combination Gel
Completed Phase 1

Find a Location

Who is running the clinical trial?

Health DecisionsLead Sponsor
30 Previous Clinical Trials
13,477 Total Patients Enrolled
Population CouncilOTHER
51 Previous Clinical Trials
62,555 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,321 Total Patients Enrolled

Media Library

Nestorone + Testosterone Combination Gel (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03452111 — Phase 2
Male Birth Control Research Study Groups: Nestorone (NES) + testosterone (T) combined gel
Male Birth Control Clinical Trial 2023: Nestorone + Testosterone Combination Gel Highlights & Side Effects. Trial Name: NCT03452111 — Phase 2
Nestorone + Testosterone Combination Gel (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03452111 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation open to individuals below the age of 40?

"This experiment stipulates that only individuals aged 18-50 can participate. There are 52 studies for those below the legal age and 394 more suited to elderly patients."

Answered by AI

Who is eligible for inclusion in this research endeavor?

"This medical experiment is open to 420 males aged 18 to 50. To be considered eligible, the male participant must agree to use an accepted form of contraception with his female partner (documented in Appendix 11) during suppression and recovery phases; have a BMI < 33 kg/m2; and not suffer from infertility."

Answered by AI

What indications is Nestorone + Testosterone Combination Gel primarily being prescribed for?

"Nestorone + Testosterone Combination Gel is typically utilized to assist with vanishing testis syndrome, but can also be beneficial in managing a variety of other medical conditions including breast, puberty and delayed growth complications as well as gonadotrophin releasing hormone deficiency."

Answered by AI

Are there still vacancies available for prospective participants in this research trial?

"Affirmative. Clinicaltrials.gov reveals that this research project, which commenced on October 25th 2018, is actively searching for participants. 420 patients need to be accepted across 8 distinct medical centres."

Answered by AI

What prior research has been conducted with regards to the pairing of Nestorone and Testosterone Combination Gel?

"The Nestorone + Testosterone Combination Gel was first examined in 2004 by the USC/Norris Comprehensive Cancer Center and Hospital. Currently, there are 195 successfully concluded experiments involving this medication, with 29 ongoing trials that largely take place in Sacramento, California."

Answered by AI

Has the Nestorone + Testosterone Combination Gel been officially endorsed by the FDA?

"Our team at Power has assigned Nestorone + Testosterone Combination Gel a safety rating of 2, as the clinical trials to date support its safety despite the lack of efficacy data."

Answered by AI

How many medical centers are offering access to this experiment?

"Potential participants can find 8 medical sites offering this study, with notable centres including UC Davis Health in Sacramento, Comprehensive Women's Health Center in Denver and University of Pennsylvania Medical Center in Philadelphia."

Answered by AI

To what extent is this medical trial recruiting participants?

"The clinical trial requires 420 individuals complying with the inclusion criteria to partake. Patients may join this research from various locations, like UC Davis Health in Sacramento and Comprehensive Women's Health Center located in Denver."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Comprehensive Women's Health Center
UC Davis Health
The Lunquist Institute at Harbor-UCLA Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

What questions have other patients asked about this trial?

Is this a paid trial?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

How responsive is this trial?

Most responsive sites:
  1. UC Davis Health: < 48 hours
Typically responds via
Average response time
  • < 2 Days
~65 spots leftby Apr 2025