NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel (NES-1)

December 3, 2014 updated by: William Bremner, University of Washington

A Randomized, Open Label Clinical Trial to Evaluate if Nestorone Gel Has Gonadotropin Suppressive Activity and if Nestorone in Combination With Testosterone Will Have an Additive Effect on Gonadotropin Suppression When Applied Transdermally in Healthy Men

The purpose of this study is to determine the usefulness of two transdermal gels to be used in the future development for a male contraceptive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The success of hormonal male contraception depends on the near complete suppression of spermatogenesis without producing any untoward effects on libido or other androgen-dependent functions or any other adverse events. The treatment with androgen alone has geen shown to be highly effective in Asian men but less effective in non-Asian men in clinical trials. To increase the efficacy of androgen alone treatment on spermatogenesis, combined regimens of a progestin and an androgen have shown promising results. The steady-state delivery of a progestin and an androgen by transdermal gel application would be a user-friendly delivery method as compared to injectable or implant approaches. Nestorone (NES) is a synthetic progestin that does not have any androgenic and estrogenic activity and is not expected to have some of the undesirable side effects of other drugs.

We propose to evaluate whether NES gel alone or in combination with T gel applied transdermally will result in more effective suppression of gonadotropins than NES or T gel applied alone in healthy men. Fifty healthy male subjects, age 18-50 will be enrolled at each center (2 sites).

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90509
        • Harbor-UCLA Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy men
  • Aged 18-50 years
  • With normal clinical chemistry, serum levels of testosterone, PSA, gonadotropins within normal limits, and sperm concentration greater than 20 million/mL
  • Subject or his partner willing to use a recognized effective method of contraception

Exclusion Criteria:

  • Men not living in area of clinics
  • Clinically significant abnormal findings at screening
  • Elevated PSA greater than 4
  • Partners who are pregnant
  • Abnormal laboratory values, liver or kidney dysfunction
  • Sperm counts below 20 million/mL.
  • Use of androgens or body building substances within 6 months of enrollment,
  • Blood pressure greater than 140/90, history of hypertension, including hypertension controlled with treatment
  • History of primary testicular disease or disorder of the hypothalamic-pituitary axis
  • Hypersensitivity of progestins
  • History of venous thromboembolism
  • Benign or malignant liver tumors
  • Active liver disease, history of reproductive dysfunction including vasectomy or infertility
  • History of active or chronic cardiac, renal, hepatic or prostatic disease
  • Diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight)
  • Known or suspected alcoholism or drug abuse
  • Known dermatitis or severe skin disorder

Men desiring fertility within 6 months or 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
100 mg Testosterone gel daily for 3 weeks
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Names:
  • Testim
Active Comparator: 2
2 mg Nestorone gel daily for 3 weeks
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 3
4 mg Nestorone gel daily for 3 weeks
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 4
100 mg Testosterone gel + 2 mg Nestorone gel
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Names:
  • Testim
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 5
100 mg Testosterone gel + 4 mg Nestorone gel
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Names:
  • Testim
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 6
100 mg Testosterone Gel + 6 mg Nestorone Gel daily for 3 weeks
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Names:
  • Testim
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 7
100 mg Testosterone Gel + 8 mg Nestorone gel daily for 3 weeks
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Names:
  • Testim
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- To determine the gonadotropin suppressive activity of Nestorone (NES) Gel at two doses and T gel at one dose alone or in combination over a 3-week period. Serum levels of gonadotropins will be assessed in all subjects.
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the effects on serum levels of total and free testosterone and SHBG and measure serum levels of NES gel.
Time Frame: 3 weeks
3 weeks
Safety measured laboratory evaluations, vitals, pre- and post treatment physical exam results and PSA levels
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: William J Bremner, MD, PhD, University of Washington
  • Principal Investigator: Christina Wang, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26852-D
  • HHSN27500002;
  • 04-3792-D 02 (Other Identifier: UW Human Subjects Division)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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