Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: Testosterone; Drug: Nestorone®

• Registration Number: NCT00891228
• Lead Sponsor: Health Decisions

Brief Summary

To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study Start: 2009-05
• Study First Posted: 2009-05-01
• Primary Completion: 2010-05
• Study Completion: 2011-11
• Results First Submitted: 2016-04-08
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Results First Posted: 2018-05-24
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Men who meet any of the following criteria are NOT eligible for enrollment in the trial:

1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit
2. Men not living in the catchment's area of the clinic or within a reasonable distance from the site
3. Clinically significant abnormal findings at screening
4. Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values
5. Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
6. Sperm concentration below 15 million/mL in more than one of three screening samples
7. Use of androgens or body building substances within 6 months before first screening visit
8. Diastolic (D) blood pressure (BP) ≥ 85 and Systolic (S) BP ≥ 135 mm Hg; (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)
9. History of hypertension, including hypertension controlled with treatment
10. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
11. Known hypersensitivity to progestins
12. Family or personal history of venous thromboembolism
13. Benign or malignant liver tumors; active liver disease
14. History of breast carcinoma
15. Known history of reproductive dysfunction including vasectomy or infertility
16. Known history of cardiac, renal, hepatic or prostatic disease
17. A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above)
18. History of sleep apnea
19. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance
20. Known dermatitis or severe skin disorder
21. Partner is known to be pregnant
22. Men desiring fertility within the first 24 weeks of study participation.

Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone Gel 10 g and Nestorone® 0 mg per day	Nestorone®	Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone Gel 10 g and Nestorone® 8 mg per day	Nestorone®	Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day	Nestorone®	Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone Gel 10 g and Nestorone® 0 mg per day	Testosterone	Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone Gel 10 g and Nestorone® 8 mg per day	Testosterone	Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day	Testosterone	Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.

Primary Outcome Measures

Name	Time	Method
The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.	24 Weeks

Secondary Outcome Measures

Name	Time	Method
The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.	24 Weeks
The Number of Men Who Have Azoospermia	24 Weeks
The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.	24 Weeks
The Impact on Sperm Morphology in Men Who Are Not Azoospermic	24 weeks

Trial Locations

Locations (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA; 🇺🇸 Torrance, California, United States

University of Washington; 🇺🇸 Seattle, Washington, United States