Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2015-10-31
2019-08-31
Brief Summary
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Detailed Description
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The primary outcome measures to be evaluated is the change in the Sabbatsberg Sexual Self-rating Scale (SSS) total score over 12 weeks. The 4-week frequency of Satisfactory Sexual Events (SSEs) and the Female Sexual Distress Scale-Revised (FSDS-R) will be also evaluate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Testosterone 500 mcg / Biolipid B2
The arm, is part of a randomized, double-blind, placebo-controlled, parallel group trial.
The arm have 35 women. It consists of a 12-week treatment phase involving three study visits and one telephone contact at week 7 of the treatment.
Testosterone
It consists of a 12-week treatment with 300mcg of transdermal testosterone phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.
Participants will be submitted to a physical examination including vital signs and breast and pelvic examination. Women who met the eligibility criteria is invited to attend a baseline randomization visit. They will be randomly assigned in a 1:1 ratio to receive a transdermal testosterone nanoemulsion (0.8g per dose) delivering 300 mcg/day testosterone or an identical placebo provided by Evidence Pharmaceuticals LTDA, SP, BRAZIL.
Women are asked to return all unused pumps, and treatment compliance was checked by counting weighting returned packs at their final visit.
Placebo
The arm, is part of a randomized, double-blind, placebo-controlled, parallel group trial.
The arm have 35 women. It consists of a 4-week screening period plus a 12-week treatment phase involving three study visits and one telephone contact at week 7 of the treatment.
Participants will be attended at the Federal University of São Paulo / Post Graduation Program in São Paulo, Brazil for their study visits.
Placebo
It consists of a 12-week treatment with placebo phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.
Interventions
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Testosterone
It consists of a 12-week treatment with 300mcg of transdermal testosterone phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.
Participants will be submitted to a physical examination including vital signs and breast and pelvic examination. Women who met the eligibility criteria is invited to attend a baseline randomization visit. They will be randomly assigned in a 1:1 ratio to receive a transdermal testosterone nanoemulsion (0.8g per dose) delivering 300 mcg/day testosterone or an identical placebo provided by Evidence Pharmaceuticals LTDA, SP, BRAZIL.
Women are asked to return all unused pumps, and treatment compliance was checked by counting weighting returned packs at their final visit.
Placebo
It consists of a 12-week treatment with placebo phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diminished libido;
* Sexual behavior complaints;
* No evidence of severe clinical depression;
* General good health based on history and physical examination.
Exclusion Criteria
* Poor feelings for their partner;
* Had received pharmacotherapy for depression within 8 weeks before screening
* Taking medication known to interfere with normal sexual function (such as α-blockers and β-blockers);
* Recent psychiatric or systemic illness;
* Uncontrolled hypertension (blood pressure\>160/95mmHg),
* Unstable cardiovascular disease,
* Genital bleeding;
* Use of psychoactive medications, alcohol excess consumption or any other drug abuse;
* Women who had under gone treatment for acne, depression, dyspareunia.
30 Years
85 Years
FEMALE
Yes
Sponsors
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Farmacias Evidence Ltda
UNKNOWN
Lemos laboratório de Análises Clínicas
UNKNOWN
University Potiguar
OTHER
Responsible Party
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Principal Investigators
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Ivaldo Silva, PhD
Role: STUDY_DIRECTOR
Federal University of São Paulo
Locations
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Gynelogical Center
Fortaleza, Ceará, Brazil
University Potiguar
Natal, Rio Grande do Norte, Brazil
Marco Botelho
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Marco A Botelho, PhD
Role: primary
Dinalva B Queiroz, MSc
Role: backup
Dinalva B Queiroz, PhD
Role: primary
Ivaldo Silva, PhD
Role: primary
Role: backup
References
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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.
Other Identifiers
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UNIFESP/Evidence
Identifier Type: -
Identifier Source: org_study_id