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Sponsored by: |
Beersheva Mental Health Center |
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Information provided by: | Beersheva Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00140153 |
The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal testosterone has been shown to improve sexual function in women after oophorectomy (Shifren et al, Transdermal testosterone treatment in women with impaired sexual function after oophorectomy, New England Journal of Medicine, 343; 682-8, 2000). In laboratory measures of sexual arousal, a single application of transdermal testosterone enhanced vaginal blood and increased erotic fantasy in normal volunteer women in the laboratory setting, four hours after application (Tuiten et al, Can sublingual testosterone increase subjective and physiological measures of laboratory-induced sexual arousal?, Arch Gen Psychiatry, 59;465,2002). We therefore planned a study of transdermal testosterone (25mg) marketed as Androgel in female hypoactive sexual desire disorder. Patients are recruited from the sexology clinics at Soroka Hospital and the Beersheva Mental Health Center. They are randomized to Androgel or placebo and given 10 packets and instructed on application to the abdomen and shoulders, four hours before planned intercourse. Patients unable to discuss planned intercourse with their partner are offered psychosexual counseling and those still unable after three sessions are excluded. After one month patients on active Androgel are crossed over to placebo or vice versa. Patients self-rate sexual response after each intercourse using the Brief Index of Sexual Functioning for Women, and Arizona Sexual Experiences Scale (ASEX)-Female and are rated in interview at the end of each month of treatment using the Sexual Function Questionnaire (SFQ-V1). Our prn technique avoids the androgenizing side effects of continuous daily treatment.
Condition | Intervention | Phase |
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Hypoactive Sexual Desire Disorder |
Drug: testosterone gel (Androgel) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Official Title: | Transdermal Testosterone Gel Prn Application for Hypoactive Sexual Desire Disorder in Women: A Controlled Study |
Estimated Enrollment: | 20 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 21 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
pre-menopausal females, hypoactive sexual disorder, age 21-40, able to plan intercourse with partner -
Exclusion Criteria:
-
Study ID Numbers: | BMHC-3973 |
Study First Received: | August 31, 2005 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00140153 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
androgel female sexuale dysfunction controlled double-blind testosterone |
Sexual Dysfunctions, Psychological Signs and Symptoms Testosterone Mental Disorders Neurologic Manifestations |
Methyltestosterone Hypokinesia Dyskinesias Testosterone 17 beta-cypionate |
Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Sexual and Gender Disorders |
Hormones Pharmacologic Actions Anabolic Agents Pathologic Processes Therapeutic Uses Androgens |