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
  Purpose

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.


Condition Intervention Phase
Female Sexual Arousal Disorder
Hypoactive Sexual Desire Disorder
Drug: bremelanotide
Phase 2

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

Further study details as provided by Palatin Technologies:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 612
Study Start Date: June 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382719

  Hide Study Locations
Locations
United States, Alabama
Site 56
Birmingham, Alabama, United States, 35209
Site 26
Huntsville, Alabama, United States, 35801
Site 64
Mobile, Alabama, United States, 36608
United States, Arizona
Site 45
Chandler, Arizona, United States, 85224
Site 39
Phoenix, Arizona, United States, 85032
Site 25
Tucson, Arizona, United States, 85712
United States, Arkansas
Site 78
Hot Springs, Arkansas, United States, 71901
Site 16
Jonesboro, Arkansas, United States, 72401
United States, California
Site 52
National City, California, United States, 91950
Site 73
Newport Beach, California, United States, 92880
Site 80
Sacramento, California, United States, 95821
Site 12
San Diego, California, United States, 92120
United States, Colorado
Site 37
Denver, Colorado, United States, 80218
Site 40
Lakewood, Colorado, United States, 80228
United States, Connecticut
Site 8
Avon, Connecticut, United States, 06117
Site 75
Farmington, Connecticut, United States, 06032
Site 33
New London, Connecticut, United States, 06320
United States, District of Columbia
Site 32
Washington, District of Columbia, United States, 20036
United States, Florida
Site 10
Aventura, Florida, United States, 33180
Site 27
Fort Myers, Florida, United States, 33916
Site 66
Melbourne, Florida, United States, 32935
Site 61
Orlando, Florida, United States, 32806
Site 1
West Palm Beach, Florida, United States, 33401
United States, Georgia
Site 82
Atlanta, Georgia, United States, 30328
Site 55
Decatur, Georgia, United States, 30030
United States, Illinois
Site 70
Chicago, Illinois, United States, 60654
Site 54
Peoria, Illinois, United States, 61602
United States, Indiana
Site 63
South Bend, Indiana, United States, 46545
United States, Kansas
Site 13
Wichita, Kansas, United States, 67226
United States, Kentucky
Site 48
Lexington, Kentucky, United States, 40509
United States, Louisiana
Site 57
Zachary, Louisiana, United States, 70791
United States, Maryland
Site 9
Baltimore, Maryland, United States, 21093
Site 60
Rockville, Maryland, United States, 20850
United States, Missouri
Site 74
St. Louis, Missouri, United States, 63141
United States, Nebraska
Site 35
Lincoln, Nebraska, United States, 68510
United States, Nevada
Site 24
Las Vegas, Nevada, United States, 89128
Site 72
Las Vegas, Nevada, United States, 89113
United States, New York
Site 18
New York, New York, United States, 10016
Site 38
Purchase, New York, United States, 10577
United States, North Carolina
Site 3
Raleigh, North Carolina, United States, 27612
Site 47
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site 23
Beachwood, Ohio, United States, 44122
Site 69
Canton, Ohio, United States, 44718
Site 71
Cincinnati, Ohio, United States, 45249
Site 19
Cleveland, Ohio, United States, 44124
Site 30
Columbus, Ohio, United States, 43213
Site 81
Englewood, Ohio, United States, 45322
United States, Oregon
Site 2
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Site 42
Philadelphia, Pennsylvania, United States, 19107
Site 77
Pittsburgh, Pennsylvania, United States, 15206
United States, Rhode Island
Site 43
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Site 58
Greer, South Carolina, United States, 29650
Site 49
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Site 53
Chattanooga, Tennessee, United States, 37404
United States, Texas
Site 59
Corpus Christi, Texas, United States, 78414
Site 31
Dallas, Texas, United States, 75234
Site 76
Dallas, Texas, United States, 75231
Site 17
Houston, Texas, United States, 77054
Site 62
San Antonio, Texas, United States, 78229
United States, Utah
Site 50
Murray, Utah, United States, 84123
Site 36
Sandy, Utah, United States, 84070
United States, Virginia
Site 7
Charlottesville, Virginia, United States, 22903
Site 68
Norfolk, Virginia, United States, 23502
Site 65
Richmond, Virginia, United States, 23294
United States, Washington
Site 22
Seattle, Washington, United States, 98105
Canada, British Columbia
Site 4
North Vancouver, British Columbia, Canada, V7N 2H5
Canada, Ontario
Site 41
Barrie, Ontario, Canada, L4M 7G1
Site 21
Burlington, Ontario, Canada, L7R4G1
Sponsors and Collaborators
Palatin Technologies
Investigators
Study Director: Jeffrey Edelson, MD, FRCPC Palatin Technologies, Inc.
  More Information

No publications provided

Responsible Party: Palatin Technologies
ClinicalTrials.gov Identifier: NCT01382719     History of Changes
Other Study ID Numbers: PT-141-54
Study First Received: June 24, 2011
Results First Received: September 5, 2013
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Palatin Technologies:
FSAD
HSDD
female sexual dysfunction
FSD
Female Sexual Arousal Disorder
Hypoactive Sexual Desire Disorder

Additional relevant MeSH terms:
Hypokinesia
Sexual Dysfunctions, Psychological
Disease
Sexual Dysfunction, Physiological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sexual and Gender Disorders
Mental Disorders
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Alpha-MSH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014