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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Potiguar
• Collaborators: Federal Institute of Science and Technology of Ceara; Universidade Federal do Ceara
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.