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Completed

NCT Number: NCT02215434

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

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.

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Key information

Conditions

Sex Behavior Behavior Genital Diseases Sexual Behavior Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Potiguar

Natal, Rio Grande do Norte, 59060, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biolipid B2 (blanked/placebo)

Drug

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

Testosterone, Transdermal, Behavior

Drug

Transdermal 0.5% testosterone Biolipid/B2

Other names: Transdermal testosterone Biolipid/B2

Primary outcomes

  1. satisfactory sexual events

    Time frame: 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 outcomes

  1. Total testosterone and SHBG levels at screening and after 12 weeks of treatment.

    Time frame: 12 weeks

    Total testosterone and SHBG levels were determined at screening and week 12.

Other outcomes

  1. Safety of transdermal Testosterone Biolipid B2 effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Potiguar

Other

Collaborators

  • Federal Institute of Science and Technology of Ceara
  • Universidade Federal do Ceara

Registry information

Official study title

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

Acronym: TESTOSTERONE

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Aug 13, 2014
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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