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

NCT01382719 | Completed Phase 2 Results DMC

• 1 other identifier: PT-141-54
• Study Type: interventional
• Target: 612
• Locations: 2 countries
• Sites: 68

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.

Conditions

Female Sexual Arousal Disorder; Hypoactive Sexual Desire Disorder

Keywords

FSAD; HSDD; female sexual dysfunction; FSD; Female Sexual Arousal Disorder; Hypoactive Sexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index

  4-12 weeks from baseline to end of study (total study duration 20 weeks)

• Satisfaction With Arousal as Measured by GAQ Question 1

  4-12 weeks from baseline to end of study (total study duration 20 weeks)

• Desire Domain From Female Sexual Function Index

  4-12 weeks from baseline to end of study (total study duration 20 weeks)

• Satisfaction With Desire as Measured by GAQ Question 2

  4-12 weeks from baseline to end of study (total study duration 20 weeks)

• Quality of Relationship With Partner as Measured by GAQ Question 4

  4-12 weeks from baseline to end of study (total study duration 20 weeks)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

bremelanotide arm 1

EXPERIMENTAL

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

bremelanotide arm 2

EXPERIMENTAL

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

bremelanotide arm 3

EXPERIMENTAL

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

Interventions

bremelanotide DRUG

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.

Also known as: PT-141

Placebo; bremelanotide arm 1; bremelanotide arm 2; bremelanotide arm 3

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palatin Technologies, Inc: lead

Study Sites (68)

Site 56

Birmingham, Alabama, 35209, United States

Location

Site 26

Huntsville, Alabama, 35801, United States

Location

Site 64

Mobile, Alabama, 36608, United States

Location

Site 45

Chandler, Arizona, 85224, United States

Location

Site 39

Phoenix, Arizona, 85032, United States

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Site 25

Tucson, Arizona, 85712, United States

Location

Site 78

Hot Springs, Arkansas, 71901, United States

Location

Site 16

Jonesboro, Arkansas, 72401, United States

Location

Site 52

National City, California, 91950, United States

Location

Site 73

Newport Beach, California, 92880, United States

Location

Site 80

Sacramento, California, 95821, United States

Location

Site 12

San Diego, California, 92120, United States

Location

Site 37

Denver, Colorado, 80218, United States

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Site 40

Lakewood, Colorado, 80228, United States

Location

Site 8

Avon, Connecticut, 06117, United States

Location

Site 75

Farmington, Connecticut, 06032, United States

Location

Site 33

New London, Connecticut, 06320, United States

Location

Site 32

Washington D.C., District of Columbia, 20036, United States

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Site 10

Aventura, Florida, 33180, United States

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Site 27

Fort Myers, Florida, 33916, United States

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Site 66

Melbourne, Florida, 32935, United States

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Site 61

Orlando, Florida, 32806, United States

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Site 1

West Palm Beach, Florida, 33401, United States

Location

Site 82

Atlanta, Georgia, 30328, United States

Location

Site 55

Decatur, Georgia, 30030, United States

Location

Site 70

Chicago, Illinois, 60654, United States

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Site 54

Peoria, Illinois, 61602, United States

Location

Site 63

South Bend, Indiana, 46545, United States

Location

Site 13

Wichita, Kansas, 67226, United States

Location

Site 48

Lexington, Kentucky, 40509, United States

Location

Site 57

Zachary, Louisiana, 70791, United States

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Site 9

Baltimore, Maryland, 21093, United States

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Site 60

Rockville, Maryland, 20850, United States

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Site 74

St Louis, Missouri, 63141, United States

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Site 35

Lincoln, Nebraska, 68510, United States

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Site 72

Las Vegas, Nevada, 89113, United States

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Site 24

Las Vegas, Nevada, 89128, United States

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Site 18

New York, New York, 10016, United States

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Site 38

Purchase, New York, 10577, United States

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Site 3

Raleigh, North Carolina, 27612, United States

Location

Site 47

Winston-Salem, North Carolina, 27103, United States

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Site 23

Beachwood, Ohio, 44122, United States

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Site 69

Canton, Ohio, 44718, United States

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Site 71

Cincinnati, Ohio, 45249, United States

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Site 19

Cleveland, Ohio, 44124, United States

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Site 30

Columbus, Ohio, 43213, United States

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Site 81

Englewood, Ohio, 45322, United States

Location

Site 2

Eugene, Oregon, 97401, United States

Location

Site 42

Philadelphia, Pennsylvania, 19107, United States

Location

Site 77

Pittsburgh, Pennsylvania, 15206, United States

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Site 43

Warwick, Rhode Island, 02886, United States

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Site 58

Greer, South Carolina, 29650, United States

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Site 49

Mt. Pleasant, South Carolina, 29464, United States

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Site 53

Chattanooga, Tennessee, 37404, United States

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Site 59

Corpus Christi, Texas, 78414, United States

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Site 76

Dallas, Texas, 75231, United States

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Site 31

Dallas, Texas, 75234, United States

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Site 17

Houston, Texas, 77054, United States

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Site 62

San Antonio, Texas, 78229, United States

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Site 50

Murray, Utah, 84123, United States

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Site 36

Sandy City, Utah, 84070, United States

Location

Site 7

Charlottesville, Virginia, 22903, United States

Location

Site 68

Norfolk, Virginia, 23502, United States

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Site 65

Richmond, Virginia, 23294, United States

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Site 22

Seattle, Washington, 98105, United States

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Site 4

North Vancouver, British Columbia, V7N 2H5, Canada

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Site 41

Barrie, Ontario, L4M 7G1, Canada

Location

Site 21

Burlington, Ontario, L7R4G1, Canada

Location

Related Publications (2)

• 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.

  PMID: 34559353 DERIVED

• 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.

  PMID: 27181790 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

bremelanotide

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Jeffrey Edelson, MD, FRCPC
• Organization: Palatin Technologies, Inc.

jedelson@palatin.com

(609) 495-2200

Study Officials

• Jeffrey Edelson, MD, FRCPC

  Palatin Technologies, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 18, 2014
• Results First Posted: April 14, 2014

Record last verified: 2014-12

Locations

US (65); CA (3)