Clinical Trial: Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors

Brief Summary: The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.

Detailed Summary: There is a growing body of scientific literature to suggest that sexual functioning is one of the most distressing problems experienced by breast cancer survivors. Vaginal dryness, dyspareunia (pain during sexual intercourse), and decreased libido are common complaints among breast cancer patients. With increasing use of aromatase inhibitors which are associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming even more prominent. This study will evaluate the safety and tolerability of the ESTRING and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.
Sponsor: University of California, San Francisco

Current Primary Outcome: Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range [ Time Frame: 12 Weeks ]

Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.


Original Primary Outcome: Evaluate safety, based on serial measurements of serum estradiol levels, of testosterone cream or the ESTRING administered for relief of vaginal dryness and/or decreased libido related to aromatase inhibitor therapy in early breast cancer patients [ Time Frame: Study Completion ]

Current Secondary Outcome:

  • Serum Estradiol (E2) [ Time Frame: 12 weeks ]
    serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)
  • Matched E2 by Commercial and Research (RIA) Analyses [ Time Frame: baseline, 4 weeks ]
    Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women
  • Total Testosterone Levels [ Time Frame: 12 weeks ]
    By serum ultrasensitive total testosterone test (Quest Diagnostics)
  • Sexual Quality of Life [ Time Frame: Baseline, Week 4, Week 12 ]
    Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.
  • Sexual Satisfaction [ Time Frame: Baseline, Week 4, Week 12 ]
    Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked "Overall, how satisfactory to you is your sexual relationship with your partner?" Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory).
  • Change in Vaginal Epithelium Scores [ Time Frame: Baseline, 12 weeks ]
    During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.


Original Secondary Outcome:

  • Document the systemic estradiol and testosterone levels at several time points [ Time Frame: Study Completion ]
  • Compare standard clinical laboratory measurements of serum estradiol with values of serum estradiol as measured by an ultrasenstive assay in a research laboratory [ Time Frame: Study Completion ]


Information By: University of California, San Francisco

Dates:
Date Received: June 11, 2008
Date Started: March 2007
Date Completion:
Last Updated: May 27, 2014
Last Verified: May 2014