DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women

Information source: University Potiguar
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sex Behavior

Intervention: Biolipid B2 (blanked/placebo) (Drug); Testosterone, Transdermal, Behavior (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Potiguar

Official(s) and/or principal investigator(s):
MARCO A BOTELHO, M.Sc., Ph.D, Study Director, Affiliation: University Potiguar
Dinalva B Queiroz, PhD, Principal Investigator, Affiliation: University Potiguar


Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia. Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder (HSDD) in women has been demonstrated in studies including naturally and surgically menopausal women, either alone or in combination with estrogen, with or without progestin therapy.

Clinical Details

Official title: Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: satisfactory sexual events

Secondary outcome: Total testosterone and SHBG levels at screening and after 12 weeks of treatment.

Detailed description: Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress. There is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido. Testosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment. Trials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants. Whether testosterone will benefit women with HSDD who are taking an antidepressant is not known. The primary aim of this study was to examine the effects of transdermal testosterone therapy with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing treatment-emergent low libido. The primary study outcome was the change in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS). In line with previous studies of women without depression, efficacy was measured by the change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general well-being, depression, and mood status. In this present study these factors will be analized in 12 weeks interval


Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Female.


Inclusion Criteria:

- a body mass index between 18 and 35 kg/m2

- diminished libido complaints

- no evidence of severe clinical depression

- participants in good health based on history and physical examination.

Exclusion Criteria:

- a past history of neurological disorder

- recent psychiatric or systemic illness

- use of psychoactive medications

- alcohol excess consumption or any other drug abuse.

- women who had under gone treatment for cardiovascular disease, genital bleeding,

acne, depression, dyspareunia or those who had received oral androgen therapy in the previous 3 months were excluded

- in addition women taking medications known to interfere with sex steroid metabolism

were also excluded.

Locations and Contacts

University Potiguar, Natal, RN 59060, Brazil
Additional Information


Starting date: September 2009
Last updated: August 12, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017