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Hypoactive Sexual Desire DisorderPhase 3HSDDNCT02333071

1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3 study testing Bremelanotide in people with Hypoactive Sexual Desire Disorder, run by Palatin Technologies, Inc at 91 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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Hypoactive Sexual Desire Disorder
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
723 participants
Where
91 sitesin 2 countries
Study dates
Dec 2014to 30 Jun 2017
Phase
Phase 3
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Has met diagnostic criteria for HSDD for at least 6 months
  • Is willing and able to understand and comply with all study requirements
  • Has a normal pelvic examination at screening

Main Exclusion Criteria:

  • Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
  • Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

Trial locations and contacts

91 sites in 2 countries.

91 sites in 2 countries

United States87 sites

  • Palatin Clinical Site 140

    Akron, Ohio, 44311

  • Palatin Clinical Site 124

    Albuquerque, New Mexico, 87106

  • Palatin Clinical Site 162

    Anderson, South Carolina, 29621

  • Palatin Clinical Site 159

    Annapolis, Maryland, 21401

  • Palatin Clinical Site 183

    Bangor, Maine, 04401

  • Palatin Clinical Site 122

    Beachwood, Ohio, 44122

  • Palatin Clinical Site 180

    Billings, Montana, 59102

  • Palatin Clinical Site 163

    Bingham Farms, Michigan, 48025

  • Palatin Clinical Site 121

    Birmingham, Alabama, 35211

  • Palatin Clinical Site 143

    Bluffton, South Carolina, 29910

  • Palatin Clinical Site 119

    Boston, Massachusetts, 02131

  • Palatin Clinical Site 130

    Bradenton, Florida, 34208

  • Palatin Clinical Site 174

    Bryan, Texas, 77802

  • Palatin Clinical Site 160

    Centennial, Colorado, 80239

  • Palatin Clinical Site 137

    Charlotte, North Carolina, 28209

  • Palatin Clinical Site 103

    Charlottesville, Virginia, 22903

  • Palatin Clinical Site 151

    Cincinnati, Ohio, 45227

  • Palatin Clinical Site 185

    Colorado Springs, Colorado, 80907

  • Palatin Clinical Site 112

    Columbus, Ohio, 43213

  • Palatin Clinical Site 113

    Dallas, Texas, 75231

  • Palatin Clinical Site 116

    Decatur, Georgia, 30030

  • Palatin Clinical Site 115

    Englewood, Ohio, 45322

  • Palatin Clinical Site 194

    Eunice, Louisiana, 70535

  • Palatin Clinical Site 179

    Evansville, Indiana, 47710

  • Palatin Clinical Site 139

    Fargo, North Dakota, 58103

  • Palatin Clinical Site 128

    Hollywood, Florida, 33024

  • Palatin Clinical Site 110

    Huntsville, Alabama, 35801

  • Palatin Clinical Site 134

    Jacksonville, Florida, 32256

  • Palatin Clinical Site 169

    Jenkintown, Pennsylvania, 19046

  • Palatin Clinical Site 189

    Johnson City, New York, 13790

  • Palatin Clinical Site 165

    Lafayette, Indiana, 47905

  • Palatin Clinical Site 111

    Las Vegas, Nevada, 89106

  • Palatin Clinical Site 125

    Las Vegas, Nevada, 89119

  • Palatin Clinical Site 109

    Las Vegas, Nevada, 89128

  • Palatin Clinical Site 195

    Las Vegas, Nevada, 89128

  • Palatin Clinical Site 166

    Little Rock, Arkansas, 72205

  • Palatin Clinical Site 191

    Louisville, Kentucky, 40291

  • Palatin Clinical Site 132

    Medford, Oregon, 97504

  • Palatin Clinical Site 172

    Media, Pennsylvania, 19063

  • Palatin Clinical Site 108

    Melbourne, Florida, 32934

  • Palatin Clinical Site 161

    Memphis, Tennessee, 38119

  • Palatin Clinical Site 171

    Meridian, Idaho, 83642

  • Palatin Clinical Site 193

    Middleton, Wisconsin, 53562

  • Palatin Clinical Site 154

    Mishawaka, Indiana, 46545

  • Palatin Clinical Site 106

    Mobile, Alabama, 36608

  • Palatin Clinical Site 120

    Moorestown, New Jersey, 08057

  • Palatin Clinical Site 114

    Mt. Pleasant, South Carolina, 29464

  • Palatin Clinical Site 145

    Mt. Pleasant, South Carolina, 29464

  • Palatin Clinical Site 100

    Murray, Utah, 84123

  • Palatin Clinical Site 129

    Nashville, Tennessee, 37203

  • Palatin Clinical Site 102

    National City, California, 91950

  • Palatin Clinical Site 186

    New Orleans, Louisiana, 70119

  • Palatin Clinical Site 107

    New York, New York, 10016

  • Palatin Clinical Site 192

    Norfolk, Nebraska, 68701

  • Palatin Clinical Site 164

    Oceanside, California, 92056

  • Palatin Clinical Site 182

    Olive Branch, Mississippi, 38654

  • Palatin Clinical Site 168

    Omaha, Nebraska, 68114

  • Palatin Clinical Site 152

    Orange, California, 92868

  • Palatin Clinical Site 105

    Orlando, Florida, 32801

  • Palatin Clinical Site 155

    Overland Park, Kansas, 66202

  • Palatin Clinical Site 123

    Plainsboro, New Jersey, 08536

  • Palatin Clinical Site 158

    Port Jefferson, New York, 11777

  • Palatin Clinical Site 146

    Portland, Oregon, 97210

  • Palatin Clinical Site 127

    Poughkeepsie, New York, 12601

  • Palatin Clinical Site 181

    Rochester, Michigan, 48307

  • Palatin Clinical Site 190

    Rochester, New York, 14609

  • Palatin Clinical Site 188

    Sacramento, California, 95821

  • Palatin Clinical Site 118

    San Antonio, Texas, 78229

  • Palatin Clinical Site 141

    San Diego, California, 92103

  • Palatin Clinical Site 142

    Savannah, Georgia, 31406

  • Palatin Clinical Site 149

    Scottsdale, Arizona, 85251

  • Palatin Clinical Site 131

    South Miami, Florida, 33143

  • Palatin Clinical Site 133

    Spokane, Washington, 99207

  • Palatin Clinical Site 170

    St Louis, Missouri, 63141

  • Palatin Clinical Site 144

    St. Petersburg, Florida, 33709

  • Palatin Clinical Site 176

    Sugar Land, Texas, 77479

  • Palatin Clinical Site 150

    Tacoma, Washington, 98405

  • Palatin Clinical Site 157

    Tucson, Arizona, 85712

  • Palatin Clinical Site 138

    Virginia Beach, Virginia, 23456

  • Palatin Clinical Site 187

    Walnut Creek, California, 94598

  • Palatin Clinical Site 117

    Warwick, Rhode Island, 02886

  • Palatin Clinical Site 126

    Watertown, Massachusetts, 02472

  • Palatin Clinical Site 184

    West Des Moines, Iowa, 50266

  • Palatin Clinical Site 101

    West Palm Beach, Florida, 33401

  • Palatin Clinical Site 104

    Wichita, Kansas, 67211

  • Palatin Clinical Site 135

    Winston-Salem, North Carolina, 27103

  • Palatin Clinical Site 156

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada4 sites

  • Palatin Clinical Site 304

    Halifax, Nova Scotia, B35 1M7

  • Palatin Clinical Site 303

    Kentville, Nova Scotia, B4N 4K9

  • Palatin Clinical Site 302

    Saint Romuald, Quebec, G6W 5M6

  • Palatin Clinical Site 301

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Read the detailed description

This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).

The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.

Primary Objective

  • To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Secondary Objectives

  • To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
  • To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
  • To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
  • To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.
Being tested
Bremelanotide, Placebo
Keywords
HSDD, Female 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 BMT, PT-141

    A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)

  • PlaceboOther

    Also called PBO

    Placebo

Study groups in NCT02333071
Study groupRoleWhat they receive
Bremelanotide (BMT/BMT)Experimental(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
Receives: Drug: Bremelanotide
Placebo (PBO/BMT)Placebo comparator(Main Study) PBO administered SC on an as-desired basis for 24 weeks (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
Receives: Drug: Bremelanotide; Other: Placebo

What is being measured

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

  1. Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.

    As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain.

    FSFI = Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Its six subscales assess desire, arousal, lubrication, orgasm, satisfaction, and pain, by summing individual items that comprise the subscale and multiplying the sum by a factor, resulting in a score ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  2. Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)

    As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (Female Sexual Distress Scale - Desire Arousal Orgasm) (item 13).: co-primary endpoint - FSDS-DAO bothered by low desire item 13.

    Responses range from 0 (never) to 4 (always). Decreasing scores on this scale represent an increase in sexual desire (positive outcome).

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Secondary outcomes (13)

  1. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration

    Patient's change, from baseline to end of study (EOS), in the number of Satisfying Sexual Events (SSEs), as measured by a response of 'Yes' to question 10 (Q10) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). The end point was calculated as the number of events during the last 4 weeks of treatment with Q10 = Yes minus the number of baseline events with Q10 = Yes.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  2. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R

    Scores range from 0 (no desire) to 3 (high desire) for an individual encounter. Change from baseline is computed as the mean of the scores from all encounters for a subject in the last 28 days minus the mean of the scores from all encounters for the subject in the last 28 days before Visit 3. Only FSEP-R data pertaining to encounters recorded within 72 hours of the encounter are included.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  3. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R

    Patient's change, from baseline to end of study (EOS), in mean satisfaction with desire score, as measured by a response to question 4 (Q4) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). Responses range from 1 (Not at all satisfied) to 4 (Completely satisfied).

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  4. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score

    FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  5. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score

    FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function.

    The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  6. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  7. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  8. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO

    FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm. The outcome reported is the mean score from the 15-item self assessment. The result is on a scale ranging from 0 ("never") to 4 ("always").

    A higher score indicates a worse outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  9. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)

    FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function.

    The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a better outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  10. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs

    Change from Baseline to EOS in the total number of satisfying sexual events SSEs that occurred within 16 hours of a study drug dosing and reported within 72 hours. A higher value indicates a better outcome.

    Measured: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

  11. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase

    FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function.

    The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

    Measured: 24 weeks (Main Study)

  12. Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase

    FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 ("never") to 4 ("always"). A higher score indicates a worse outcome.

    The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) for FSDS-DAO Item 13 (feeling bothered by low sexual desire).

    Measured: 24 weeks (Main Study)

  13. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase

    Mean change from Baseline to EOS in the number of satisfying sexual events SSEs that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number reflects a positive outcome.

    Measured: 24 weeks (Main Study)

Timeline

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

  1. First posted7 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2016
  4. Study completion30 Jun 2017

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
723 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02333071
Sponsor's protocol ID
BMT-301
Other IDs
Reconnect Study
Acronym
HSDD
Status last verified
Dec 2020
First submitted
28 Dec 2014
Last updated
9 Apr 2021
Data monitoring committee
Yes

Publications

  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

    PubMed 10782451

  • Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res. 2024 May;61(4):540-561. doi: 10.1080/00224499.2023.2175192. Epub 2023 Feb 21.

    PubMed 36809187

  • Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). 2022 Feb;31(2):171-182. doi: 10.1089/jwh.2021.0191.

    PubMed 35147466

  • Koochaki P, Revicki D, Wilson H, Pokrzywinski R, Jordan R, Lucas J, Williams LA, Sadiq A, Krop J. The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. J Womens Health (Larchmt). 2021 Apr;30(4):587-595. doi: 10.1089/jwh.2020.8460. Epub 2021 Feb 3.

    PubMed 33538638

  • Revicki DA, Althof SE, Derogatis LR, Kingsberg SA, Wilson H, Sadiq A, Krop J, Jordan R, Lucas J. Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder. J Patient Rep Outcomes. 2020 Oct 8;4(1):82. doi: 10.1186/s41687-020-00241-6.

    PubMed 33033885

  • Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019 Nov;134(5):909-917. doi: 10.1097/AOG.0000000000003514.

    PubMed 31599847

  • Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019 Nov;134(5):899-908. doi: 10.1097/AOG.0000000000003500.

    PubMed 31599840

  • Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clin Ther. 2017 Mar;39(3):514-526.e14. doi: 10.1016/j.clinthera.2017.01.018. Epub 2017 Feb 9.

    PubMed 28189361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bremelanotide in people with Hypoactive Sexual Desire Disorder, run by Palatin Technologies, Inc at 91 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?

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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Dec 2020). 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?

Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. (time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)). The study lists 2 primary outcomes in all. 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 NCT02333071, which also lists 8 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 9 Apr 2021.

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