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

Sex Behavior Clinical Trial

— TESTOSTERONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215434
• Other study ID #: UNP/CNPq02
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2014
• Last updated: August 12, 2014
• Start date: September 2009
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: University Potiguar
• Contact: n/a
• Is FDA regulated: No
• Health authority: BRAZIL: Agencia Nacional de Vigilância Sanitária
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sex Behavior

Intervention

Drug:
• Biolipid B2 (blanked/placebo)
the intervention will be the comparison effects of both emulsions
• Testosterone, Transdermal, Behavior
Transdermal 0.5% testosterone Biolipid/B2

Locations

Country	Name	City	State
Brazil	University Potiguar	Natal	RN

Sponsors (3)

Lead Sponsor	Collaborator
University Potiguar	Federal Institute of Science and Technology of Ceara, Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of transdermal Testosterone Biolipid B2 effects	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.	12 weeks	Yes
Primary	satisfactory sexual events	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.	12 weeks	Yes
Secondary	Total testosterone and SHBG levels at screening and after 12 weeks of treatment.	Total testosterone and SHBG levels were determined at screening and week 12.	12 weeks	Yes

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