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

NCT02215434 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-08-13

No results posted yet for this study

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

Interventions

DRUG

Biolipid B2 (blanked/placebo)

the intervention will be the comparison effects of both emulsions

DRUG

Testosterone, Transdermal, Behavior

Transdermal 0.5% testosterone Biolipid/B2

Sponsors & Collaborators

  • Universidade Federal do Ceara

    collaborator OTHER

  • Federal Institute of Science and Technology of Ceara

    collaborator UNKNOWN

  • University Potiguar

    lead OTHER

Principal Investigators

  • MARCO A BOTELHO, M.Sc., Ph.D · University Potiguar

  • Dinalva B Queiroz, PhD · University Potiguar

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-04-30
Completion
2014-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215434 on ClinicalTrials.gov