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

NCT ID: NCT02215434

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-08-31

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

Conditions

Sex Behavior

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Biolipid B2 (blanked/placebo)

Intervention Type: DRUG

the intervention will be the comparison effects of both emulsions

Testosterone, Transdermal, Behavior

Intervention Type: DRUG

Transdermal 0.5% testosterone Biolipid/B2

Testosterone, Transdermal, Behavior

Testosterone 0.5%, daily, 3 months

Group Type: ACTIVE_COMPARATOR

Biolipid B2 (blanked/placebo)

Intervention Type: DRUG

the intervention will be the comparison effects of both emulsions

Testosterone, Transdermal, Behavior

Intervention Type: DRUG

Transdermal 0.5% testosterone Biolipid/B2

Interventions

Biolipid B2 (blanked/placebo)

the intervention will be the comparison effects of both emulsions

Intervention Type: DRUG

Testosterone, Transdermal, Behavior

Transdermal 0.5% testosterone Biolipid/B2

Intervention Type: DRUG

Other Intervention Names

Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil; Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil; Transdermal testosterone Biolipid/B2

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Ceara

OTHER

Sponsor Role: collaborator

Federal Institute of Science and Technology of Ceara

UNKNOWN

Sponsor Role: collaborator

University Potiguar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARCO A BOTELHO, M.Sc., Ph.D

Role: STUDY_DIRECTOR

University Potiguar

Dinalva B Queiroz, PhD

Role: PRINCIPAL_INVESTIGATOR

University Potiguar

Locations

University Potiguar

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 24519196 (View on PubMed)

Related Links

http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322014000200075&lng=en&nrm=iso&tlng=en

Article

Other Identifiers

UNP/CNPq02

Identifier Type: -

Identifier Source: org_study_id