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

University Potiguar

Status and phase: Completed; Phase 2

Conditions: Sex Behavior

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02215434

UNP/CNPq02

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Biolipid B2 (blanked/placebo)

Placebo Comparator group

Description:

The study is a single-center, single-blind, placebo-controlled, parallel group trial. It consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination. They were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL. The testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks.

Treatment:

Drug: Testosterone, Transdermal, Behavior

Drug: Biolipid B2 (blanked/placebo)

Testosterone, Transdermal, Behavior

Active Comparator group

Description:

Testosterone 0.5%, daily, 3 months

Treatment:

Drug: Testosterone, Transdermal, Behavior

Drug: Biolipid B2 (blanked/placebo)