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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01382719 (opens ClinicalTrials.gov in a new tab)Other idPT-141-54
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
612 participants (actual)
Sponsor
Palatin Technologies, Inc · Industry
Design
Randomized · Triple masking
Countries
2 countries

United States, Canada

Start
Jun 2011
Primary completion
Sept 2012
Completion
Sept 2012
First posted
27 Jun 2011 (estimated)
Last update posted
18 Dec 2014 (estimated)
Conditions
Female Sexual Arousal Disorder · Hypoactive Sexual Desire Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 2

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

    NCT01382719

    Jun 2011 to Sept 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • bremelanotideDrug

Arms4

  • 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.

  • 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.

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    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 outcomes(6)

  1. 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)

    Registry description

    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).

  2. 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)

    Registry description

    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).

  3. Desire Domain From Female Sexual Function Index

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

    Registry description

    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. 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)

    Registry description

    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).

  5. 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)

    Registry description

    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).

  6. FSDS-DAO Total Score

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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.

The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)

GroupValue (SSEs)Spread
Placebo0.22.29
Bremelanotide Arm 10.63.55
Bremelanotide Arm 20.71.81
Bremelanotide Arm 30.82.86
Secondary and other outcome results(6)
Secondary outcomeMean· 4-12 weeks from baseline to end of study (total study duration 20 weeks)

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

GroupValue (units on a scale)Spread
Placebo0.511.371
Bremelanotide Arm 10.351.457
Bremelanotide Arm 20.711.112
Bremelanotide Arm 31.061.146
Secondary outcomeMean· 4-12 weeks from baseline to end of study (total study duration 20 weeks)

Satisfaction With Arousal as Measured by GAQ Question 1

GroupValue (units on a scale)Spread
Placebo0.41.37
Bremelanotide Arm 10.31.43
Bremelanotide Arm 20.51.46
Bremelanotide Arm 30.91.18
Secondary outcomeMean· 4-12 weeks from baseline to end of study (total study duration 20 weeks)

Desire Domain From Female Sexual Function Index

GroupValue (units on a scale)Spread
Placebo0.391.075
Bremelanotide Arm 10.331.093
Bremelanotide Arm 20.550.794
Bremelanotide Arm 30.951.003
Secondary outcomeMean· 4-12 weeks from baseline to end of study (total study duration 20 weeks)

Satisfaction With Desire as Measured by GAQ Question 2

GroupValue (units on a scale)Spread
Placebo0.41.31
Bremelanotide Arm 10.31.32
Bremelanotide Arm 20.81.44
Bremelanotide Arm 30.91.20
Secondary outcomeMean· 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

GroupValue (units on a scale)Spread
Placebo0.31.20
Bremelanotide Arm 10.31.24
Bremelanotide Arm 20.41.22
Bremelanotide Arm 30.61.22
Secondary outcomeMean· 4 - 12 weeks from baseline to end of study (total study duration 20 weeks)

FSDS-DAO Total Score

GroupValue (units on a scale)Spread
Placebo-6.813.57
Bremelanotide Arm 1-7.413.47
Bremelanotide Arm 2-9.210.79
Bremelanotide Arm 3-13.112.93

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placeboidentical formulation without active ingredient–3 / 9749 / 97
Bremelanotide Arm 1low dose 0.75 mg BMT–1 / 10064 / 100
Bremelanotide Arm 2middle dose 1.25 mg BMT–1 / 9961 / 99
Bremelanotide Arm 3high dose 1.75 mg BMT–1 / 9867 / 98

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2021

Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm.

Derogatis et al. 2021Journal of patient-reported outcomescited by 23

PMID 34559353PMC8463644DOI 10.1186/s41687-021-00359-1PUB-34559353

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 2016

6 results

Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.

Clayton et al. 2016Women's health (London, England)cited by 58

PMID 27181790PMC5384512DOI 10.2217/whe-2016-0018PUB-27181790

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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