CompletedPhase 2

Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception

United States420 participantsStarted 2018-10-25

Plain-language summary

The long term objective is to develop a gel to be used as a male contraceptive.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
✓. 18 to 50 years of age, at the enrollment visit;
✓. BMI \< 33 kg/m2;
✓. No history of androgen use in the six months prior to the first screening visit;
✓. Agreement to use an effective method of contraception with his female partner (refer to Appendix 11 for acceptable forms of contraception) during the suppression and the first 7 days of the recovery phase and then only use the experimental method during the efficacy phase of the study;
✓. In the opinion of the investigator, the male subject is willing and able to comply with the protocol, understand and sign an informed consent and HIPAA form;
✓. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions and has duly signed the informed consent form (ICF);
✓. Sexually active with a female partner (as specified below) with whom he has been in a stable, mutually monogamous relationship for at least 1 year prior to screening and with whom he intends to remain in a relationship for the duration of the study;

Exclusion criteria

✕. Men participating in another clinical trial involving an investigational drug within the last 30 days (or within five half-lives of the investigational drug, whichever is longer) prior to the first screening visit.
✕. Men not living in the catchment's area of the study site or within a reasonable distance from the site.
✕. Clinically significant abnormal findings at screening per the Investigator's medical judgment.
✕. Elevated PSA levels ≥ 4 ng/mL.
✕. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction.
✕. Use of androgens or other anabolic steroids that may suppress gonadotropins within 6 months prior to the first screening visit.
✕. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 2 measurements will be used to determine eligibility).
✕. History of hypertension, including hypertension controlled with treatment.

What they're measuring

Contraceptive efficacy provided by daily application of NES/T gel for 52 wks during the efficacy phase of the study determined using Kaplan-Meier methods to estimate the 12-mth cumulative pregnancy probability in the efficacy(evaluable cycles)population.

Timeframe: 12 months

Trial details

NCT IDNCT03452111

SponsorPremier Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-06

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