AzTrials
AzTrials

Female Sexual Arousal DisorderPhase 2NCT01382719

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

A Phase 2 study testing bremelanotide in people with Female Sexual Arousal Disorder and Hypoactive Sexual Desire Disorder, run by Palatin Technologies, Inc at 68 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 21 years and older, women only
What is being tested?
bremelanotide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
612 participants
Where
68 sitesin 2 countries
Study dates
Jun 2011to Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

68 sites in 2 countries.

68 sites in 2 countries

United States65 sites

  • Site 82

    Atlanta, Georgia, 30328

  • Site 10

    Aventura, Florida, 33180

  • Site 8

    Avon, Connecticut, 06117

  • Site 9

    Baltimore, Maryland, 21093

  • Site 23

    Beachwood, Ohio, 44122

  • Site 56

    Birmingham, Alabama, 35209

  • Site 69

    Canton, Ohio, 44718

  • Site 45

    Chandler, Arizona, 85224

  • Site 7

    Charlottesville, Virginia, 22903

  • Site 53

    Chattanooga, Tennessee, 37404

  • Site 70

    Chicago, Illinois, 60654

  • Site 71

    Cincinnati, Ohio, 45249

  • Site 19

    Cleveland, Ohio, 44124

  • Site 30

    Columbus, Ohio, 43213

  • Site 59

    Corpus Christi, Texas, 78414

  • Site 76

    Dallas, Texas, 75231

  • Site 31

    Dallas, Texas, 75234

  • Site 55

    Decatur, Georgia, 30030

  • Site 37

    Denver, Colorado, 80218

  • Site 81

    Englewood, Ohio, 45322

  • Site 2

    Eugene, Oregon, 97401

  • Site 75

    Farmington, Connecticut, 06032

  • Site 27

    Fort Myers, Florida, 33916

  • Site 58

    Greer, South Carolina, 29650

  • Site 78

    Hot Springs, Arkansas, 71901

  • Site 17

    Houston, Texas, 77054

  • Site 26

    Huntsville, Alabama, 35801

  • Site 16

    Jonesboro, Arkansas, 72401

  • Site 40

    Lakewood, Colorado, 80228

  • Site 72

    Las Vegas, Nevada, 89113

  • Site 24

    Las Vegas, Nevada, 89128

  • Site 48

    Lexington, Kentucky, 40509

  • Site 35

    Lincoln, Nebraska, 68510

  • Site 66

    Melbourne, Florida, 32935

  • Site 64

    Mobile, Alabama, 36608

  • Site 49

    Mt. Pleasant, South Carolina, 29464

  • Site 50

    Murray, Utah, 84123

  • Site 52

    National City, California, 91950

  • Site 33

    New London, Connecticut, 06320

  • Site 18

    New York, New York, 10016

  • Site 73

    Newport Beach, California, 92880

  • Site 68

    Norfolk, Virginia, 23502

  • Site 61

    Orlando, Florida, 32806

  • Site 54

    Peoria, Illinois, 61602

  • Site 42

    Philadelphia, Pennsylvania, 19107

  • Site 39

    Phoenix, Arizona, 85032

  • Site 77

    Pittsburgh, Pennsylvania, 15206

  • Site 38

    Purchase, New York, 10577

  • Site 3

    Raleigh, North Carolina, 27612

  • Site 65

    Richmond, Virginia, 23294

  • Site 60

    Rockville, Maryland, 20850

  • Site 80

    Sacramento, California, 95821

  • Site 62

    San Antonio, Texas, 78229

  • Site 12

    San Diego, California, 92120

  • Site 36

    Sandy City, Utah, 84070

  • Site 22

    Seattle, Washington, 98105

  • Site 63

    South Bend, Indiana, 46545

  • Site 74

    St Louis, Missouri, 63141

  • Site 25

    Tucson, Arizona, 85712

  • Site 43

    Warwick, Rhode Island, 02886

  • Site 32

    Washington D.C., District of Columbia, 20036

  • Site 1

    West Palm Beach, Florida, 33401

  • Site 13

    Wichita, Kansas, 67226

  • Site 47

    Winston-Salem, North Carolina, 27103

  • Site 57

    Zachary, Louisiana, 70791

Other trials in United States

Canada3 sites

  • Site 41

    Barrie, Ontario, L4M 7G1

  • Site 21

    Burlington, Ontario, L7R4G1

  • Site 4

    North Vancouver, British Columbia, V7N 2H5

Other trials in Canada

About this study

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)

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.

Being tested
bremelanotide
Keywords
FSAD, HSDD, female sexual dysfunction, FSD, Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder
Medical subject headings
Sexual Dysfunctions, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bremelanotideDrug

    Also called PT-141

    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.

Study groups in NCT01382719
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSame 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.
Receives: Drug: bremelanotide
bremelanotide arm 1ExperimentalLow 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.
Receives: Drug: bremelanotide
bremelanotide arm 2ExperimentalMiddle 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.
Receives: Drug: bremelanotide
bremelanotide arm 3ExperimentalHigh 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.
Receives: Drug: bremelanotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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).

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

  5. 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).

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382719
Sponsor's protocol ID
PT-141-54
Status last verified
Dec 2014
First submitted
24 Jun 2011
Last updated
18 Dec 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34559353

  • 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.

    PubMed 27181790

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bremelanotide in people with Female Sexual Arousal Disorder and Hypoactive Sexual Desire Disorder, run by Palatin Technologies, Inc at 68 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382719, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in