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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215434
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborators:
Universidade Federal do Ceara
Federal Institute of Science and Technology of Ceara
Information provided by (Responsible Party):
University Potiguar

Brief 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.


Condition or disease Intervention/treatment Phase
Sex Behavior Drug: Biolipid B2 (blanked/placebo) Drug: Testosterone, Transdermal, Behavior Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Study Start Date : September 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Biolipid B2 (blanked/placebo)

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.

Drug: Biolipid B2 (blanked/placebo)
the intervention will be the comparison effects of both emulsions
Other Names:
  • Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil
  • Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil

Drug: Testosterone, Transdermal, Behavior
Transdermal 0.5% testosterone Biolipid/B2
Other Name: Transdermal testosterone Biolipid/B2

Active Comparator: Testosterone, Transdermal, Behavior
Testosterone 0.5%, daily, 3 months
Drug: Biolipid B2 (blanked/placebo)
the intervention will be the comparison effects of both emulsions
Other Names:
  • Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil
  • Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil

Drug: Testosterone, Transdermal, Behavior
Transdermal 0.5% testosterone Biolipid/B2
Other Name: Transdermal testosterone Biolipid/B2




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total testosterone and SHBG levels at screening and after 12 weeks of treatment. [ Time Frame: 12 weeks ]
    Total testosterone and SHBG levels were determined at screening and week 12.


Other Outcome Measures:
  1. Safety of transdermal Testosterone Biolipid B2 effects [ Time Frame: 12 weeks ]

    Safety is assessed by comparing the rates of adverse events in the two treatment groups. Androgenic side effects including the frequency of facial depilation per month, hirsutism by the Ferriman-Gallwey scale (range 0-4 for each of nine body regions), acne by the Palatsi scale and clitoromegaly by examination were assessed at screening and the final visit.

    We also monitor vital signs and concomitant medications.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215434


Locations
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Brazil
University Potiguar
Natal, RN, Brazil, 59060
Sponsors and Collaborators
University Potiguar
Universidade Federal do Ceara
Federal Institute of Science and Technology of Ceara
Investigators
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Study Director: MARCO A BOTELHO, M.Sc., Ph.D University Potiguar
Principal Investigator: Dinalva B Queiroz, PhD University Potiguar

Additional Information:
Publications of Results:
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Responsible Party: University Potiguar
ClinicalTrials.gov Identifier: NCT02215434    
Other Study ID Numbers: UNP/CNPq02
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by University Potiguar:
Libido; Sexual Dysfunction; testosterone
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents