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
Summary
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
Eligibility
Minimum age: 18 Years.
Maximum age: 89 Years.
Gender(s): Female.
Criteria:
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
Article
Starting date: September 2009
Last updated: August 12, 2014
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