MenopausePhase 2Biolipid/B2NCT02445716
Transdermal Testosterone Nanoemulsion in Women Libido
A Phase 2 study testing Testosterone in people with Menopause, run by University Potiguar at 3 sites in Brazil.
Trial 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)… Read more about this study
- Who is it for?
- Ages 30 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesBrazil
- Study dates
- Oct 2015to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Gynelogical Center
Fortaleza, Ceará, 60115-191
Marco A Botelho, PhD, ++558586685000, marcobotelho1@gmail.com
Dinalva B Queiroz, MSc, ++558588864388, dinafarma@gmail.com
- Recruiting
University Potiguar
Natal, Rio Grande do Norte, 59060
Dinalva B Queiroz, PhD, 558588864388, dinafarma@gmail.com
Dinalva B Queiroz, MSc, PhD
- Recruiting
Marco Botelho
São Paulo, 04023-062
Ivaldo Silva, PhD, +551155764718, ivaldosilva@gmail.com
+558586685000, marcobotelho1@gmail.com
About this study
Official title: Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed description
The aim of this study is to investigate the efficacy of transdermal testosterone nanoemulsion (TNT) as a treatment for SSRI/SNRI-emergent loss of libido.
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
- Menopause
- Being tested
- Testosterone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Transdermal Testosterone Nanoemulsion
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone 500 mcg / Biolipid B2 | Active comparator | 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. Receives: Drug: Testosterone |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Potiguar
- Sponsor type
- University, hospital or other
- Collaborators
- Farmacias Evidence Ltda, Lemos laboratório de Análises Clínicas
- Responsible party
- Sponsor
- Investigators
- Ivaldo Silva, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445716
- Sponsor's protocol ID
- UNIFESP/Evidence
- Acronym
- Biolipid/B2
- Status last verified
- Oct 2017
- First submitted
- 7 May 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24519196
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02445716
- Acronym / sponsor ID
- Biolipid/B2 / UNIFESP/Evidence
- Conditions
- Menopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University PotiguarUniversity, hospital or other
- Collaborators
- Farmacias Evidence Ltda, Lemos laboratório de Análises Clínicas
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to investigate the efficacy of transdermal testosterone nanoemulsion (TNT) as a treatment for SSRI/SNRI-emergent loss of libido.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone 500 mcg / Biolipid B2 | Active comparator | Drug: TestosteroneThe 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 comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneAlso: Transdermal Testosterone NanoemulsionIt 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. | Drug | Testosterone 500 mcg / Biolipid B2 |
| PlaceboIt 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. | Drug | Placebo |
Primary outcome
Change in sexual function measured by the Sexual Self-rating Scale (SSS)
Time frame: Baseline and 12 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Results publication: PubMed 24519196Botelho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivaldo Silva, PhD study director
Federal University of São Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone in people with Menopause, run by University Potiguar at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARCO BOTELHO (+558586685000, marcobotelho1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual function measured by the Sexual Self-rating Scale (SSS) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.