Transdermal Testosterone Nanoemulsion in Women Libido
Biolipid/B2
1 other identifier
interventional
70
1 country
3
Brief Summary
This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75 years, with treatment-emergent loss of libido will be randomly allocated to the treatment with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2015
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedOctober 25, 2017
October 1, 2017
2 years
May 7, 2015
October 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in sexual function measured by the Sexual Self-rating Scale (SSS)
The SSS is a 21-item, multiple-choice questionnaire containing seven domains (sexual interest, sexual activity, satisfaction with sexual life, experience of sexual pleasure, sexual fantasy, orgasmic capacity, and sexual relevancy). Each item has five levels scored from 0 to 4. Possible composite scores range from 0 (low sexuality) to 84 (high sexuality). It was developed to use in premenopausal and postmenopausal women . Its validity and reliability have been independently established.
Baseline and 12 weeks
Study Arms (2)
Testosterone 500 mcg / Biolipid B2
ACTIVE COMPARATORThe 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.
Placebo
PLACEBO COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- a body mass index between 18 and 27 kg/m2;
- Diminished libido;
- Sexual behavior complaints;
- No evidence of severe clinical depression;
- General good health based on history and physical examination.
You may not qualify if:
- a past history of neurological disorder;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Potiguarlead
- Farmacias Evidence Ltdacollaborator
- Lemos laboratório de Análises Clínicascollaborator
Study Sites (3)
Gynelogical Center
Fortaleza, Ceará, 60115-191, Brazil
University Potiguar
Natal, Rio Grande do Norte, 59060, Brazil
Marco Botelho
São Paulo, 04023-062, Brazil
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: 24519196RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ivaldo Silva, PhD
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2015
First Posted
May 15, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
August 1, 2019
Last Updated
October 25, 2017
Record last verified: 2017-10