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

NCT00891228 | Completed Phase 1 Results DMC

• 1 other identifier: CCN007
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Contraception

Keywords

Contraception; Male Contraception; Suppression of Sperm Production

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

Testosterone Gel 10 g and Nestorone® 0 mg per day

PLACEBO COMPARATOR

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.

Drug: Testosterone; Drug: Nestorone®

Testosterone Gel 10 g and Nestorone® 8 mg per day

EXPERIMENTAL

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.

Drug: Testosterone; Drug: Nestorone®

Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day

EXPERIMENTAL

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.

Drug: Testosterone; Drug: Nestorone®

Interventions

Testosterone DRUG

Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.

Testosterone Gel 10 g and Nestorone® 0 mg per day; Testosterone Gel 10 g and Nestorone® 8 mg per day; Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day

Nestorone® DRUG

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 Nestorone® mL gel) by pressing two times with 2 mL dispenser head.

Testosterone Gel 10 g and Nestorone® 8 mg per day

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men who meet all the following criteria are eligible for enrollment in the trial:
• Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
• to 50 years of age
• BMI ≤ 33 calculated as weight in Kg/ (height in cm) 2
• No history of hormonal therapy use in the last six months prior to the first screening visit
• Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, use double-barrier contraception) during the course of the study treatment and recovery phase
• In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form

You may not qualify if:

• Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
• Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit
• Men not living in the catchment's area of the clinic or within a reasonable distance from the site
• Clinically significant abnormal findings at screening
• Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values
• Sperm concentration below 15 million/mL in more than one of three screening samples
• Use of androgens or body building substances within 6 months before first screening visit
• 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)
• History of hypertension, including hypertension controlled with treatment
• Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
• Known hypersensitivity to progestins
• Family or personal history of venous thromboembolism
• Benign or malignant liver tumors; active liver disease
• History of breast carcinoma
• Known history of reproductive dysfunction including vasectomy or infertility

Sponsors & Collaborators

• Premier Research: lead
• Population Council: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA

Torrance, California, 90502, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

Testosterone; ST 1435

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: H. Trent MacKay, MD, MPH
• Organization: NICHD

mackayt@mail.nih.gov

301-435-6988

Study Officials

• Christina Wang, MD

  LA BioMedical Research Institute, Harbor-UCLA

  PRINCIPAL INVESTIGATOR

• William Bremner, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: November 1, 2011
• Last Updated: May 24, 2018
• Results First Posted: May 24, 2018

Record last verified: 2018-04

Locations

US (2)