Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies
ClinicalTrials.gov Identifier:
NCT01382719
First received: June 24, 2011
Last updated: March 7, 2014
Last verified: March 2014

June 24, 2011
March 7, 2014
June 2011
September 2012   (final data collection date for primary outcome measure)
The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) [ Time Frame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. ] [ Designated as safety issue: No ]
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site.
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSE) [ Time Frame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSE), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = 'Yes" minus the number of baseline events with FSEP-R Q10 = 'Yes.'
Complete list of historical versions of study NCT01382719 on ClinicalTrials.gov Archive Site
  • Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
    The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).
  • Satisfaction With Arousal as Measured by GAQ Question 1 [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
    This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
  • Desire Domain From Female Sexual Function Index [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
    The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).
  • Satisfaction With Desire as Measured by GAQ Question 2 [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
    This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
  • Quality of Relationship With Partner as Measured by GAQ Question 4 [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
    This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is "Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner?" The score range is 1 (very much worse) to 7 (very much better).
  • FSDS-DAO Total Score [ Time Frame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
    FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, "How often do you feel: Distressed about your sex life" and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60.
A number of secondary efficacy endpoints will also be evaluated regarding bremelanotide effect on arousal, desire, distress associated with arousal and desire, and related endpoints. [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ] [ Designated as safety issue: No ]
  1. Change from baseline in the arousal domain (FSDS-DAO)
  2. Change from baseline in the desire domain (FSDS-DAO)
  3. Change from baseline in study drug benefit (GAQ)
  4. Change from baseline in total Female Sexual Function Index (FSFI)
  5. Change from baseline in the arousal domain (FSFI)
  6. Change from baseline in satisfaction with arousal (GAQ)
  7. Change from baseline in the desire domain (FSFI)
  8. Change from baseline in satisfaction with desire (GAQ)
  9. Change from baseline in quality of relationship with partner (GAQ)
  10. Change from baseline in total FSDS-DAO.
Not Provided
Not Provided
 
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
A Placebo-controlled, Randomized, Parallel Group, Dose-finding Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With FSAD (Female Sexual Arousal Disorder) and/or HSDD (Hypoactive Sexual Desire Disorder)

This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Female Sexual Arousal Disorder
  • Hypoactive Sexual Desire Disorder
Drug: bremelanotide

Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.

Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.

Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.

Other Name: PT-141
  • Placebo Comparator: Placebo
    Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
    Intervention: Drug: bremelanotide
  • Experimental: bremelanotide arm 1
    Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
    Intervention: Drug: bremelanotide
  • Experimental: bremelanotide arm 2
    Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
    Intervention: Drug: bremelanotide
  • Experimental: bremelanotide arm 3
    High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
    Intervention: Drug: bremelanotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
612
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Female, at least 21 years of age, and premenopausal Previously experienced sexual arousal during sexual activity and/or normal level of desire in the past for least 2 years.

Willing to engage in sexual activities Currently in stable relationship with a partner(male or female)for at least 6 months.

If subject has a male sexual partner, has recorded a score of "not impotent" or "minimally impotent" on Single-question Assessment of ED.

For at least 6 months before Screening, has met diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if subject's partner is male, has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue for the duration of the trial and 1 month following the last dose of trial drug.

Has a normal pelvic examination. At Screening or documented within 12 months before Screening, has:normal Pap test results with or without history of positive HPV, dysplasia, or ASCUS that has resolved or been treated;Pap test results positive for ASCUS and negative for HPV;Pap test results positive for HPV AND no ASCUS or dysplasia on Pap or condyloma present upon examination.

At Screening and Visit 2, meets all necessary questionnaire scores.

Exclusion Criteria:

Medical condition that is unstable or uncontrolled despite current therapy. History of unresolved sexual trauma or abuse. Pregnant or nursing. Lifelong anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.

Female sexual dysfunction caused by untreated endocrine disease. Has or has had any of the following: hepatitis C, other infectious hepatitis, infectious blood disorders such as HIV; myocardial infarction;stroke.

Has or has had any of the following within 12 months before Screening:chronic dyspareunia not attributable to vaginal dryness; pelvic inflammatory disease; chronic or complicated UTI, or an active STD other than herpes and condyloma; cervical dysplasia, including LGSIL and HGSIL and/or ASCUS with HPV; significant cervicitis as manifested by mucopurulent discharge from the cervix.

Has had any of the following within 6 months before Screening:≥ 2 outbreaks of genital herpes; occurrence/recurrence of clinically significant condyloma;clinically unstable angina or clinically unstable arrhythmia;significant CNS diseases;AST or ALT concentrations > 3 times the ULN;serum creatinine > 2.5 mg/dL;any other clinically significant abnormal laboratory result.

Has used prohibited medications within the 3 months before Screening:

Has currently active moderate to severe vaginitis or a clinically significant vaginal infection.

Has one or more significant gynecologic conditions . Is taking or has received treatment for psychosis, bipolar disorder, depression, and/or alcohol/substance abuse within 6 months before Screening.

Is currently receiving psychotherapy for the treatment of FSAD and/or HSDD. Has any of the following: Uncontrolled hypertension;Systolic BP of ≥ 140 mm Hg at Screening;Diastolic BP of ≥ 90 mm Hg at Screening; Treatment for hypertension that has changed in the 3 months before Screening.

Had a hysterectomy with bilateral oophorectomy. Had a hysterectomy without bilateral oophorectomy AND meets several other criteria.

Is taking contraceptives that have affected the menstrual cycle or caused amenorrhea AND did not have a normal menstrual cycle before starting the contraceptive medication.

Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01382719
PT-141-54
Yes
Palatin Technologies
Palatin Technologies
Not Provided
Study Director: Jeffrey Edelson, MD, FRCPC Palatin Technologies, Inc.
Palatin Technologies
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP