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

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382719
• Other study ID #: PT-141-54
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2011
• Last updated: December 2, 2014
• Start date: June 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2014
• Source: Palatin Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Female Sexual Arousal Disorder
• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

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.

Locations

Country	Name	City	State
Canada	Site 41	Barrie	Ontario
Canada	Site 21	Burlington	Ontario
Canada	Site 4	North Vancouver	British Columbia
United States	Site 82	Atlanta	Georgia
United States	Site 10	Aventura	Florida
United States	Site 8	Avon	Connecticut
United States	Site 9	Baltimore	Maryland
United States	Site 23	Beachwood	Ohio
United States	Site 56	Birmingham	Alabama
United States	Site 69	Canton	Ohio
United States	Site 45	Chandler	Arizona
United States	Site 7	Charlottesville	Virginia
United States	Site 53	Chattanooga	Tennessee
United States	Site 70	Chicago	Illinois
United States	Site 71	Cincinnati	Ohio
United States	Site 19	Cleveland	Ohio
United States	Site 30	Columbus	Ohio
United States	Site 59	Corpus Christi	Texas
United States	Site 31	Dallas	Texas
United States	Site 76	Dallas	Texas
United States	Site 55	Decatur	Georgia
United States	Site 37	Denver	Colorado
United States	Site 81	Englewood	Ohio
United States	Site 2	Eugene	Oregon
United States	Site 75	Farmington	Connecticut
United States	Site 27	Fort Myers	Florida
United States	Site 58	Greer	South Carolina
United States	Site 78	Hot Springs	Arkansas
United States	Site 17	Houston	Texas
United States	Site 26	Huntsville	Alabama
United States	Site 16	Jonesboro	Arkansas
United States	Site 40	Lakewood	Colorado
United States	Site 24	Las Vegas	Nevada
United States	Site 72	Las Vegas	Nevada
United States	Site 48	Lexington	Kentucky
United States	Site 35	Lincoln	Nebraska
United States	Site 66	Melbourne	Florida
United States	Site 64	Mobile	Alabama
United States	Site 49	Mt. Pleasant	South Carolina
United States	Site 50	Murray	Utah
United States	Site 52	National City	California
United States	Site 33	New London	Connecticut
United States	Site 18	New York	New York
United States	Site 73	Newport Beach	California
United States	Site 68	Norfolk	Virginia
United States	Site 61	Orlando	Florida
United States	Site 54	Peoria	Illinois
United States	Site 42	Philadelphia	Pennsylvania
United States	Site 39	Phoenix	Arizona
United States	Site 77	Pittsburgh	Pennsylvania
United States	Site 38	Purchase	New York
United States	Site 3	Raleigh	North Carolina
United States	Site 65	Richmond	Virginia
United States	Site 60	Rockville	Maryland
United States	Site 80	Sacramento	California
United States	Site 62	San Antonio	Texas
United States	Site 12	San Diego	California
United States	Site 36	Sandy	Utah
United States	Site 22	Seattle	Washington
United States	Site 63	South Bend	Indiana
United States	Site 74	St. Louis	Missouri
United States	Site 25	Tucson	Arizona
United States	Site 43	Warwick	Rhode Island
United States	Site 32	Washington	District of Columbia
United States	Site 1	West Palm Beach	Florida
United States	Site 13	Wichita	Kansas
United States	Site 47	Winston-Salem	North Carolina
United States	Site 57	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Palatin Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)	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.	4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.	No
Secondary	Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index	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).	4-12 weeks from baseline to end of study (total study duration 20 weeks)	No
Secondary	Satisfaction With Arousal as Measured by GAQ Question 1	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).	4-12 weeks from baseline to end of study (total study duration 20 weeks)	No
Secondary	Desire Domain From Female Sexual Function Index	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).	4-12 weeks from baseline to end of study (total study duration 20 weeks)	No
Secondary	Satisfaction With Desire as Measured by GAQ Question 2	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).	4-12 weeks from baseline to end of study (total study duration 20 weeks)	No
Secondary	Quality of Relationship With Partner as Measured by GAQ Question 4	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).	4-12 weeks from baseline to end of study (total study duration 20 weeks)	No
Secondary	FSDS-DAO Total Score	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.	4 - 12 weeks from baseline to end of study (total study duration 20 weeks)	No