Nestorone + Testosterone Combination Gel for Men

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Men+2 More
Nestorone + Testosterone Combination Gel - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a potential male contraceptive gel.

Eligible Conditions
  • Men
  • Healthy Subjects (HS)
  • Male Contraception

Treatment Effectiveness

Study Objectives

1 Primary · 26 Secondary · Reporting Duration: 24 months

12 months
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.
20 weeks
Suppression of spermatogenesis induced by daily use of the NES/T gel as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL during the suppression phase of the study.
24 months
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.
Changes from baseline in Nestorone with daily use of the NES/T gel.
Changes from baseline in Sex Hormone Binding Globulin (SHBG) with daily use of the NES/T gel.
Changes from baseline in Testosterone with daily use of the NES/T gel.
Changes from baseline in alanine aminotransferase with daily use of the NES/T gel.
Changes from baseline in albumin with daily use of the NES/T gel.
Changes from baseline in alkaline phosphatase with daily use of the NES/T gel.
Changes from baseline in aspartate transaminase with daily use of the NES/T gel.
Changes from baseline in bicarbonate with daily use of the NES/T gel.
Changes from baseline in blood urea nitrogen with daily use of the NES/T gel.
Changes from baseline in calcium with daily use of the NES/T gel.
Changes from baseline in chloride with daily use of the NES/T gel.
Changes from baseline in creatinine with daily use of the NES/T gel.
Changes from baseline in fasting glucose with daily use of the NES/T gel.
Changes from baseline in mood with daily use of the NES/T gel using the Patient Health Questionnaire-9.
Potassium
Changes from baseline in prostate function with daily use of NES/T gel using the International Prostate Symptom Score.
Changes from baseline in sexual function with daily use of the NES/T gel using the psychosexual daily questionnaire.
Changes from baseline in sodium with daily use of the NES/T gel.
Changes from baseline in total bilirubin with daily use of the NES/T gel.
Incidence of treatment emergent adverse events with daily use of the NES/T gel.
24 weeks
Length of time to recovery of spermatogenesis after daily use of NES/T gel as assessed by sperm concentration > 15 million (M)/mL during the recovery phase.
52 weeks
Maintenance of suppression of spermatogensis induced by daily use of the NE/T gel as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL during the 52 week efficacy phase of the study.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Nestorone (NES) + testosterone (T) combined gel
1 of 1

Experimental Treatment

420 Total Participants · 1 Treatment Group

Primary Treatment: Nestorone + Testosterone Combination Gel · No Placebo Group · Phase 2

Nestorone (NES) + testosterone (T) combined gel
Drug
Experimental Group · 1 Intervention: Nestorone + Testosterone Combination Gel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,809 Previous Clinical Trials
2,235,052 Total Patients Enrolled
1 Trials studying Men
100 Patients Enrolled for Men
Population CouncilOTHER
47 Previous Clinical Trials
54,097 Total Patients Enrolled
Health DecisionsLead Sponsor
30 Previous Clinical Trials
13,501 Total Patients Enrolled
1 Trials studying Men
100 Patients Enrolled for Men
Diana Blithe, PhDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2 Previous Clinical Trials
2,872 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no known infertility.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
UC Davis Health50.0%
The Lunquist Institute at Harbor-UCLA Medical Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%