NCT00229593

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

September 27, 2005

Last Update Submit

December 3, 2014

Conditions

Contraception

Keywords

Male contraceptionAndrogenProgestinSpermatogenesisGonadotropin suppressionTestosteroneNestorone

Outcome Measures

Primary Outcomes (1)

  • - 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.

    3 weeks

Secondary Outcomes (2)

  • To determine the effects on serum levels of total and free testosterone and SHBG and measure serum levels of NES gel.

    3 weeks

  • Safety measured laboratory evaluations, vitals, pre- and post treatment physical exam results and PSA levels

    3 weeks

Study Arms (7)

1

ACTIVE COMPARATOR

100 mg Testosterone gel daily for 3 weeks

Drug: Testosterone Gel

2

ACTIVE COMPARATOR

2 mg Nestorone gel daily for 3 weeks

Drug: Nestorone gel

3

ACTIVE COMPARATOR

4 mg Nestorone gel daily for 3 weeks

Drug: Nestorone gel

4

ACTIVE COMPARATOR

100 mg Testosterone gel + 2 mg Nestorone gel

Drug: Nestorone gelDrug: Testosterone Gel

5

ACTIVE COMPARATOR

100 mg Testosterone gel + 4 mg Nestorone gel

Drug: Nestorone gelDrug: Testosterone Gel

6

ACTIVE COMPARATOR

100 mg Testosterone Gel + 6 mg Nestorone Gel daily for 3 weeks

Drug: Nestorone gelDrug: Testosterone Gel

7

ACTIVE COMPARATOR

100 mg Testosterone Gel + 8 mg Nestorone gel daily for 3 weeks

Drug: Nestorone gelDrug: Testosterone Gel

Interventions

Nestorone gelDRUG

2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment

234567
Testosterone GelDRUG

100 mg Testosterone gel daily for 3 weeks

Also known as: Testim
14567

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (12)

  • Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.

    PMID: 10386821BACKGROUND

  • Anderson RA, Kinniburgh D, Baird DT. Suppression of spermatogenesis by etonogestrel implants with depot testosterone: potential for long-acting male contraception. J Clin Endocrinol Metab. 2002 Aug;87(8):3640-9. doi: 10.1210/jcem.87.8.8773.

    PMID: 12161488BACKGROUND

  • Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300.

    PMID: 8636300BACKGROUND

  • Brache V, Massai R, Mishell DR, Moo-Young AJ, Alvarez F, Salvatierra AM, Cochon L, Croxatto H, Robbins A, Faundes A. Ovarian function during use of Nestorone(R) subdermal implants. Contraception. 2000 Mar;61(3):199-204. doi: 10.1016/s0010-7824(00)00092-5.

    PMID: 10827334BACKGROUND

  • Cummings DE, Bremner WJ. Prospects for new hormonal male contraceptives. Endocrinol Metab Clin North Am. 1994 Dec;23(4):893-922.

    PMID: 7705326BACKGROUND

  • Diaz S, Schiappacasse V, Pavez M, Zepeda A, Moo-Young AJ, Brandeis A, Lahteenmaki P, Croxatto HB. Clinical trial with Nestorone subdermal contraceptive implants. Contraception. 1995 Jan;51(1):33-8. doi: 10.1016/0010-7824(94)00006-i.

    PMID: 7750282BACKGROUND

  • Gonzalo IT, Swerdloff RS, Nelson AL, Clevenger B, Garcia R, Berman N, Wang C. Levonorgestrel implants (Norplant II) for male contraception clinical trials: combination with transdermal and injectable testosterone. J Clin Endocrinol Metab. 2002 Aug;87(8):3562-72. doi: 10.1210/jcem.87.8.8710.

    PMID: 12161475BACKGROUND

  • Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A. Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55. doi: 10.1016/0010-7824(92)90140-o.

    PMID: 1591921BACKGROUND

  • Handelsman DJ, Conway AJ, Howe CJ, Turner L, Mackey MA. Establishing the minimum effective dose and additive effects of depot progestin in suppression of human spermatogenesis by a testosterone depot. J Clin Endocrinol Metab. 1996 Nov;81(11):4113-21. doi: 10.1210/jcem.81.11.8923869.

    PMID: 8923869BACKGROUND

  • Kamischke A, Heuermann T, Kruger K, von Eckardstein S, Schellschmidt I, Rubig A, Nieschlag E. An effective hormonal male contraceptive using testosterone undecanoate with oral or injectable norethisterone preparations. J Clin Endocrinol Metab. 2002 Feb;87(2):530-9. doi: 10.1210/jcem.87.2.8218.

    PMID: 11836281BACKGROUND

  • Kamischke A, Venherm S, Ploger D, von Eckardstein S, Nieschlag E. Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab. 2001 Jan;86(1):303-9. doi: 10.1210/jcem.86.1.7057.

    PMID: 11232016BACKGROUND

  • Mahabadi V, Amory JK, Swerdloff RS, Bremner WJ, Page ST, Sitruk-Ware R, Christensen PD, Kumar N, Tsong YY, Blithe D, Wang C. Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men. J Clin Endocrinol Metab. 2009 Jul;94(7):2313-20. doi: 10.1210/jc.2008-2604. Epub 2009 Apr 14.

    PMID: 19366848RESULT

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • William J Bremner, MD, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Christina Wang, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

US(2)