Clinical trial NCT01382719: Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Sexual Arousal Disorder
Hypoactive Sexual Desire Disorder
Keywords: FSAD
HSDD
female sexual dysfunction
FSD
Female Sexual Arousal Disorder
Hypoactive Sexual Desire Disorder
Lead sponsor: Palatin Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 612
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)
timeFrame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.
Secondary outcomes:
measure: Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index
timeFrame: 4-12 weeks from baseline to end of study (total study duration 20 weeks)
measure: Satisfaction With Arousal as Measured by GAQ Question 1
timeFrame: 4-12 weeks from baseline to end of study (total study duration 20 weeks)
measure: Desire Domain From Female Sexual Function Index
timeFrame: 4-12 weeks from baseline to end of study (total study duration 20 weeks)
measure: Satisfaction With Desire as Measured by GAQ Question 2
timeFrame: 4-12 weeks from baseline to end of study (total study duration 20 weeks)
measure: Quality of Relationship With Partner as Measured by GAQ Question 4
timeFrame: 4-12 weeks from baseline to end of study (total study duration 20 weeks)
measure: FSDS-DAO Total Score
timeFrame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 56
state: Alabama
city: Huntsville
country: United States
facility: Site 26
state: Alabama
city: Mobile
country: United States
facility: Site 64
state: Alabama
city: Chandler
country: United States
facility: Site 45
state: Arizona
city: Phoenix
country: United States
facility: Site 39
state: Arizona
city: Tucson
country: United States
facility: Site 25
state: Arizona
city: Hot Springs
country: United States
facility: Site 78
state: Arkansas
city: Jonesboro
country: United States
facility: Site 16
state: Arkansas
city: National City
country: United States
facility: Site 52
state: California
city: Newport Beach
country: United States
facility: Site 73
state: California
city: Sacramento
country: United States
facility: Site 80
state: California
city: San Diego
country: United States
facility: Site 12
state: California
city: Denver
country: United States
facility: Site 37
state: Colorado
city: Lakewood
country: United States
facility: Site 40
state: Colorado
city: Avon
country: United States
facility: Site 8
state: Connecticut
city: Farmington
country: United States
facility: Site 75
state: Connecticut
city: New London
country: United States
facility: Site 33
state: Connecticut
city: Washington
country: United States
facility: Site 32
state: District of Columbia
city: Aventura
country: United States
facility: Site 10
state: Florida
city: Fort Myers
country: United States
facility: Site 27
state: Florida
city: Melbourne
country: United States
facility: Site 66
state: Florida
city: Orlando
country: United States
facility: Site 61
state: Florida
city: West Palm Beach
country: United States
facility: Site 1
state: Florida
city: Atlanta
country: United States
facility: Site 82
state: Georgia
city: Decatur
country: United States
facility: Site 55
state: Georgia
city: Chicago
country: United States
facility: Site 70
state: Illinois
city: Peoria
country: United States
facility: Site 54
state: Illinois
city: South Bend
country: United States
facility: Site 63
state: Indiana
city: Wichita
country: United States
facility: Site 13
state: Kansas
city: Lexington
country: United States
facility: Site 48
state: Kentucky
city: Zachary
country: United States
facility: Site 57
state: Louisiana
city: Baltimore
country: United States
facility: Site 9
state: Maryland
city: Rockville
country: United States
facility: Site 60
state: Maryland
city: St. Louis
country: United States
facility: Site 74
state: Missouri
city: Lincoln
country: United States
facility: Site 35
state: Nebraska
city: Las Vegas
country: United States
facility: Site 72
state: Nevada
city: Las Vegas
country: United States
facility: Site 24
state: Nevada
city: New York
country: United States
facility: Site 18
state: New York
city: Purchase
country: United States
facility: Site 38
state: New York
city: Raleigh
country: United States
facility: Site 3
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 47
state: North Carolina
city: Beachwood
country: United States
facility: Site 23
state: Ohio
city: Canton
country: United States
facility: Site 69
state: Ohio
city: Cincinnati
country: United States
facility: Site 71
state: Ohio
city: Cleveland
country: United States
facility: Site 19
state: Ohio
city: Columbus
country: United States
facility: Site 30
state: Ohio
city: Englewood
country: United States
facility: Site 81
state: Ohio
city: Eugene
country: United States
facility: Site 2
state: Oregon
city: Philadelphia
country: United States
facility: Site 42
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 77
state: Pennsylvania
city: Warwick
country: United States
facility: Site 43
state: Rhode Island
city: Greer
country: United States
facility: Site 58
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Site 49
state: South Carolina
city: Chattanooga
country: United States
facility: Site 53
state: Tennessee
city: Corpus Christi
country: United States
facility: Site 59
state: Texas
city: Dallas
country: United States
facility: Site 76
state: Texas
city: Dallas
country: United States
facility: Site 31
state: Texas
city: Houston
country: United States
facility: Site 17
state: Texas
city: San Antonio
country: United States
facility: Site 62
state: Texas
city: Murray
country: United States
facility: Site 50
state: Utah
city: Sandy
country: United States
facility: Site 36
state: Utah
city: Charlottesville
country: United States
facility: Site 7
state: Virginia
city: Norfolk
country: United States
facility: Site 68
state: Virginia
city: Richmond
country: United States
facility: Site 65
state: Virginia
city: Seattle
country: United States
facility: Site 22
state: Washington
city: North Vancouver
country: Canada
facility: Site 4
state: British Columbia
city: Barrie
country: Canada
facility: Site 41
state: Ontario
city: Burlington
country: Canada
facility: Site 21
state: Ontario
Study officials:
affiliation: Palatin Technologies, Inc
name: Jeffrey Edelson, MD, FRCPC
role: STUDY_DIRECTOR
References:
citation: Derogatis LR, Revicki DA, Rosen RC, Jordan R, Lucas J, Spana C. Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm. J Patient Rep Outcomes. 2021 Sep 24;5(1):100. doi: 10.1186/s41687-021-00359-1.
citation: Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond). 2016 Jun;12(3):325-37. doi: 10.2217/whe-2016-0018. Epub 2016 May 16.