Sex BehaviorPhase 2TESTOSTERONENCT02215434
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
A Phase 2 study testing Testosterone, Transdermal, Behavior in people with Sex Behavior, run by University Potiguar at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sex Behavior
- What is being tested?
- Testosterone, Transdermal, Behavior
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Aug 2014
- 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 18 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
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.
Read the detailed description
Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.
There is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido.
Testosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment.
Trials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants.
Whether testosterone will benefit women with HSDD who are taking an antidepressant is not known.
The primary aim of this study was to examine the effects of transdermal testosterone therapy with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing treatment-emergent low libido. The primary study outcome was the change in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS).
In line with previous studies of women without depression, efficacy was measured by the change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general well-being, depression, and mood status.
In this present study these factors will be analized in 12 weeks interval
- Conditions
- Sex Behavior
- Being tested
- Biolipid B2 (blanked/placebo), Testosterone, Transdermal, Behavior
- Keywords
- Libido; Sexual Dysfunction; testosterone
- Medical subject headings
- Sexual Behavior, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolipid B2 (blanked/placebo)Drug
Also called Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil, Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil
the intervention will be the comparison effects of both emulsions
Testosterone, Transdermal, BehaviorDrug
Also called Transdermal testosterone Biolipid/B2
Transdermal 0.5% testosterone Biolipid/B2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Biolipid B2 (blanked/placebo); Drug: Testosterone, Transdermal, Behavior |
| Testosterone, Transdermal, Behavior | Active comparator | Testosterone 0.5%, daily, 3 months Receives: Drug: Biolipid B2 (blanked/placebo); Drug: Testosterone, Transdermal, Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Total testosterone and SHBG levels at screening and after 12 weeks of treatment.
Total testosterone and SHBG levels were determined at screening and week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startSep 2009
- Primary completionApr 2013
- Study completionAug 2014
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 Sex BehaviorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Potiguar
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Ceara, Federal Institute of Science and Technology of Ceara
- Responsible party
- Sponsor
- Investigators
- MARCO A BOTELHO, M.Sc., Ph.D, Study director, University PotiguarDinalva B Queiroz, PhD, Principal investigator, University Potiguar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215434
- Sponsor's protocol ID
- UNP/CNPq02
- Acronym
- TESTOSTERONE
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02215434
- Acronym / sponsor ID
- TESTOSTERONE / UNP/CNPq02
- Conditions
- Sex Behavior
- Keywords
- Libido; Sexual Dysfunction; testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University PotiguarUniversity, hospital or other
- Collaborators
- Universidade Federal do Ceara, Federal Institute of Science and Technology of Ceara
- Study start
- Sep 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Aug 2014 (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.
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.
Detailed description
Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.
There is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido.
Testosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment.
Trials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants.
Whether testosterone will benefit women with HSDD who are taking an antidepressant is not known.
The primary aim of this study was to examine the effects of transdermal testosterone therapy with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing treatment-emergent low libido. The primary study outcome was the change in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS).
In line with previous studies of women without depression, efficacy was measured by the change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general well-being, depression, and mood status.
In this present study these factors will be analized in 12 weeks interval
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biolipid B2 (blanked/placebo) | Placebo comparator | Drug: Biolipid B2 (blanked/placebo), Drug: Testosterone, Transdermal, BehaviorThe 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. |
| Testosterone, Transdermal, Behavior | Active comparator | Drug: Biolipid B2 (blanked/placebo), Drug: Testosterone, Transdermal, BehaviorTestosterone 0.5%, daily, 3 months |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Biolipid B2 (blanked/placebo)Also: Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil, Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazilthe intervention will be the comparison effects of both emulsions | Drug | Biolipid B2 (blanked/placebo), Testosterone, Transdermal, Behavior |
| Testosterone, Transdermal, BehaviorAlso: Transdermal testosterone Biolipid/B2Transdermal 0.5% testosterone Biolipid/B2 | Drug | Biolipid B2 (blanked/placebo), Testosterone, Transdermal, Behavior |
Primary outcome
satisfactory sexual events
Time frame: 12 weeks
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.
1 secondary outcome
Total testosterone and SHBG levels at screening and after 12 weeks of treatment.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- 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.
- ArticleLink provided by the sponsor.
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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.
MARCO A BOTELHO, M.Sc., Ph.D study director
University Potiguar
Dinalva B Queiroz, PhD principal investigator
University Potiguar
1 site 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, Transdermal, Behavior in people with Sex Behavior, run by University Potiguar at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfactory sexual events (time frame: 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 NCT02215434, 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 13 Aug 2014; AzTrials last refreshed its copy on 6 Nov 2026.