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

Sponsor

University Potiguar (Other)

Overall Status

Completed

CT.gov ID

NCT02215434

Collaborator

Universidade Federal do Ceara (Other), Federal Institute of Science and Technology of Ceara (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sex Behavior	Drug: Biolipid B2 (blanked/placebo) Drug: Testosterone, Transdermal, Behavior	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Biolipid B2 (blanked/placebo) 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.	Drug: Biolipid B2 (blanked/placebo) the intervention will be the comparison effects of both emulsions Other Names: Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil Drug: Testosterone, Transdermal, Behavior Transdermal 0.5% testosterone Biolipid/B2 Other Names: Transdermal testosterone Biolipid/B2
Active Comparator: Testosterone, Transdermal, Behavior Testosterone 0.5%, daily, 3 months	Drug: Biolipid B2 (blanked/placebo) the intervention will be the comparison effects of both emulsions Other Names: Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil Drug: Testosterone, Transdermal, Behavior Transdermal 0.5% testosterone Biolipid/B2 Other Names: Transdermal testosterone Biolipid/B2

Arm

Intervention/Treatment

Placebo Comparator: Biolipid B2 (blanked/placebo)

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.

Drug: Biolipid B2 (blanked/placebo)

the intervention will be the comparison effects of both emulsions

Other Names:

Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil

Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil

Drug: Testosterone, Transdermal, Behavior

Transdermal 0.5% testosterone Biolipid/B2

Other Names:

Transdermal testosterone Biolipid/B2

Active Comparator: Testosterone, Transdermal, Behavior

Testosterone 0.5%, daily, 3 months

Drug: Biolipid B2 (blanked/placebo)

the intervention will be the comparison effects of both emulsions

Other Names:

Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil

Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil

Drug: Testosterone, Transdermal, Behavior

Transdermal 0.5% testosterone Biolipid/B2

Other Names:

Transdermal testosterone Biolipid/B2

Outcome Measures

Primary Outcome Measures

satisfactory sexual events [12 weeks]
Recent studies have reported an increase in the number of satisfactory sexual events (SSEs) recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.

Secondary Outcome Measures

Total testosterone and SHBG levels at screening and after 12 weeks of treatment. [12 weeks]
Total testosterone and SHBG levels were determined at screening and week 12.

Other Outcome Measures

Safety of transdermal Testosterone Biolipid B2 effects [12 weeks]
Safety is assessed by comparing the rates of adverse events in the two treatment groups. Androgenic side effects including the frequency of facial depilation per month, hirsutism by the Ferriman-Gallwey scale (range 0-4 for each of nine body regions), acne by the Palatsi scale and clitoromegaly by examination were assessed at screening and the final visit. We also monitor vital signs and concomitant medications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.