Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00467259
First received: April 27, 2007
Last updated: November 10, 2011
Last verified: November 2011

April 27, 2007
November 10, 2011
April 2007
January 2009   (final data collection date for primary outcome measure)
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
To estimate the incidence of endometrial hyperplasia associated with 300 mcg/day testosterone transdermal system therapy in naturally postmenopausal women with hypoactive sexual desire disorder who are not using concomitant estrogen.
Complete list of historical versions of study NCT00467259 on ClinicalTrials.gov Archive Site
  • Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
  • Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Not Provided
Not Provided
Not Provided
 
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypoactive Sexual Desire Disorder
  • Drug: Testosterone Transdermal System
    Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
  • Drug: Placebo patch
    placebo patch, changed twice a week for 52 weeks
  • Placebo Comparator: Placebo
    28 cm² Placebo patch
    Intervention: Drug: Placebo patch
  • Experimental: Testosterone
    Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
    Intervention: Drug: Testosterone Transdermal System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1271
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.

Exclusion Criteria:

  • Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
Female
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467259
2007004
Yes
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Johna Lucas, MD Procter and Gamble
Warner Chilcott
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP