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

NCT02215434 | Completed Phase 2

• 1 other identifier: UNP/CNPq02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sex Behavior

Keywords

Libido; Sexual Dysfunction; testosterone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  12 weeks

Other Outcomes (1)

• Safety of transdermal Testosterone Biolipid B2 effects

  12 weeks

Study Arms (2)

Biolipid B2 (blanked/placebo)

PLACEBO COMPARATOR

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); Drug: Testosterone, Transdermal, Behavior

Testosterone, Transdermal, Behavior

ACTIVE COMPARATOR

Testosterone 0.5%, daily, 3 months

Drug: Biolipid B2 (blanked/placebo); Drug: Testosterone, Transdermal, Behavior

Interventions

Biolipid B2 (blanked/placebo) DRUG

the intervention will be the comparison effects of both emulsions

Also known as: Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil, Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil

Biolipid B2 (blanked/placebo); Testosterone, Transdermal, Behavior

Testosterone, Transdermal, Behavior DRUG

Transdermal 0.5% testosterone Biolipid/B2

Also known as: Transdermal testosterone Biolipid/B2

Biolipid B2 (blanked/placebo); Testosterone, Transdermal, Behavior

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Potiguar: lead
• Universidade Federal do Ceara: collaborator
• Federal Institute of Science and Technology of Ceara: collaborator

Study Sites (1)

University Potiguar

Natal, Rio Grande do Norte, 59060, Brazil

Location

Related 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 spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.

  PMID: 24519196 RESULT

Related Links

• Article

MeSH Terms

Conditions

Sexual Behavior; Sexual Dysfunction, Physiological

Interventions

Testosterone; Administration, Cutaneous

Condition Hierarchy (Ancestors)

Behavior; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• MARCO A BOTELHO, M.Sc., Ph.D

  University Potiguar

  STUDY DIRECTOR

• Dinalva B Queiroz, PhD

  University Potiguar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

BR (1)