Clinical trial NCT02215434: Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Official title: Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sex Behavior
Keywords: Libido; Sexual Dysfunction; testosterone
Lead sponsor: University Potiguar
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Ceara
name: Federal Institute of Science and Technology of Ceara
First posted: 2014-08-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: satisfactory sexual events
timeFrame: 12 weeks
Secondary outcomes:
measure: Total testosterone and SHBG levels at screening and after 12 weeks of treatment.
timeFrame: 12 weeks
Other outcomes:
measure: Safety of transdermal Testosterone Biolipid B2 effects
timeFrame: 12 weeks
Locations:
city: Natal
country: Brazil
facility: University Potiguar
state: RN
Study officials:
affiliation: University Potiguar
name: MARCO A BOTELHO, M.Sc., Ph.D
role: STUDY_DIRECTOR
affiliation: University Potiguar
name: Dinalva B Queiroz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.