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Hypoactive Sexual Desire DisorderPhase 3HSDDNCT02338960

2. 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
714 participants
Where
91 sitesin 2 countries
Study dates
Jan 2015to 29 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 288

    Addison, Illinois, 60101

  • Palatin Clinical Site 276

    Albuquerque, New Mexico, 87102

  • Palatin Clinical Site 267

    Allentown, Pennsylvania, 18104

  • Palatin Clinical Site 248

    Alpharetta, Georgia, 30005

  • Palatin Clinical Site 257

    Annapolis, Maryland, 21401

  • Palatin Clinical Site 235

    Arlington, Texas, 75230

  • Palatin Clinical Site 263

    Atlanta, Georgia, 30328

  • Palatin Clinical Site 230

    Austin, Texas, 78731

  • Palatin Clinical Site 204

    Aventura, Florida, 33180

  • Palatin Clinical Site 290

    Berlin, New Jersey, 08009

  • Palatin Clinical Site 258

    Beverly Hills, California, 90210

  • Palatin Clinical Site 242

    Birmingham, Alabama, 35242

  • Palatin Clinical Site 265

    Boston, Massachusetts, 02131

  • Palatin Clinical Site 271

    Canton, Ohio, 44718

  • Palatin Clinical Site 264

    Cary, North Carolina, 27518

  • Palatin Clinical Site 285

    Charleston, West Virginia, 25304

  • Palatin Clinical Site 275

    Chattanooga, Tennessee, 37403

  • Palatin Clinical Site 252

    Chicago, Illinois, 60640

  • Palatin Clinical Site 201

    Chicago, Illinois, 60654

  • Palatin Clinical Site 215

    Cincinnati, Ohio, 45249

  • Palatin Clinical Site 232

    Cleveland, Ohio, 44122

  • Palatin Clinical Site 246

    Columbus, Ohio, 43212

  • Palatin Clinical Site 273

    Coral Gables, Florida, 33134

  • Palatin Clinical Site 223

    Dallas, Texas, 75234

  • Palatin Clinical Site 212

    Denver, Colorado, 80209

  • Palatin Clinical Site 219

    Denver, Colorado, 80220

  • Palatin Clinical Site 269

    Draper, Utah, 84020

  • Palatin Clinical Site 287

    Flowood, Mississippi, 39232

  • Palatin Clinical Site 203

    Fort Myers, Florida, 33912

  • Palatin Clinical Site 255

    Gainesville, Florida, 32607

  • Palatin Clinical Site 266

    Gainesville, Florida, 32607

  • Palatin Clinical Site 256

    Garden Grove, California, 92845

  • Palatin Clinical Site 200

    Greer, South Carolina, 29650

  • Palatin Clinical Site 207

    Hot Springs, Arkansas, 71901

  • Palatin Clinical Site 208

    Houston, Texas, 77054

  • Palatin Clinical Site 277

    Indianapolis, Indiana, 46260

  • Palatin Clinical Site 216

    Jackson, Tennessee, 38305

  • Palatin Clinical Site 224

    Jupiter, Florida, 33458

  • Palatin Clinical Site 239

    Kalamazoo, Michigan, 49009

  • Palatin Clinical Site 244

    Kansas City, Missouri, 64114

  • Palatin Clinical Site 279

    Lake Charles, Louisiana, 70629

  • Palatin Clinical Site 243

    Lakewood, Colorado, 80228

  • Palatin Clinical Site 233

    Lawrenceville, New Jersey, 08648

  • Palatin Clinical Site 220

    Lincoln, Nebraska, 68510

  • Palatin Clinical Site 278

    Lincoln, Rhode Island, 02865

  • Palatin Clinical Site 291

    Los Angeles, California, 90024

  • Palatin Clinical Site 222

    Lutherville, Maryland, 21093

  • Palatin Clinical Site 221

    Mayfield Heights, Ohio, 44124

  • Palatin Clinical Site 274

    Memphis, Tennessee, 38119

  • Palatin Clinical Site 281

    Metairie, Louisiana, 70002

  • Palatin Clinical Site 259

    Moncks Corner, South Carolina, 29461

  • Palatin Clinical Site 292

    Nashville, Tennessee, 37201

  • Palatin Clinical Site 217

    New Bedford, Massachusetts, 02740

  • Palatin Clinical Site 211

    New London, Connecticut, 06320

  • Palatin Clinical Site 284

    Newport News, Virginia, 23606

  • Palatin Clinical Site 205

    Norfolk, Virginia, 23502

  • Palatin Clinical Site 270

    Oakland, California, 94612

  • Palatin Clinical Site 238

    Oklahoma City, Oklahoma, 73103

  • Palatin Clinical Site 227

    Oklahoma City, Oklahoma, 73112

  • Palatin Clinical Site 250

    Orlando, Florida, 32806

  • Palatin Clinical Site 261

    Oviedo, Florida, 32765

  • Palatin Clinical Site 286

    Paducah, Kentucky, 42003

  • Palatin Clinical Site 234

    Philadelphia, Pennsylvania, 19114

  • Palatin Clinical Site 218

    Phoenix, Arizona, 85032

  • Palatin Clinical Site 260

    Pinellas Park, Florida, 33781

  • Palatin Clinical Site 240

    Pittsburgh, Pennsylvania, 15206

  • Palatin Clinical Site 247

    Prairie Village, Kansas, 66206

  • Palatin Clinical Site 206

    Raleigh, North Carolina, 27612

  • Palatin Clinical Site 213

    Richmond, Virginia, 23294

  • Palatin Clinical Site 268

    Richmond, Virginia, 23298

  • Palatin Clinical Site 282

    Rochester, New York, 14618

  • Palatin Clinical Site 283

    Rockville, Maryland, 20852

  • Palatin Clinical Site 245

    Saginaw, Michigan, 48604

  • Palatin Clinical Site 231

    Salisbury, North Carolina, 28144

  • Palatin Clinical Site 210

    San Diego, California, 92120

  • Palatin Clinical Site 251

    San Diego, California, 92123

  • Palatin Clinical Site 214

    Seattle, Washington, 98105

  • Palatin Clinical Site 272

    Sherman Oaks, California, 91403

  • Palatin Clinical Site 280

    St Louis, Missouri, 63043

  • Palatin Clinical Site 253

    Tarzana, California, 91356

  • Palatin Clinical Site 289

    Tiffin, Ohio, 44883

  • Palatin Clinical Site 254

    Tucson, Arizona, 85712

  • Palatin Clinical Site 202

    Washington D.C., District of Columbia, 20036

  • Palatin Clinical Site 229

    Waterbury, Connecticut, 06708

  • Palatin Clinical Site 228

    West Jordan, Utah, 84088

  • Palatin Clinical Site 236

    West Palm Beach, Florida, 33409

  • Palatin Clinical Site 209

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada4 sites

  • Palatin Clinical Site 405

    Greater Sudbury, Ontario, P3E 1H5

  • Palatin Clinical Site 401

    Pointe-Claire, Quebec, H9R 4S3

  • Palatin Clinical Site 404

    Sherbrooke, Quebec, J1H 121

  • Palatin Clinical Site 400

    Vancouver, British Columbia, V6J 1S3

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, decreased desire, female sexual dysfunction
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)

  • PlaceboDrug

    Also called PBO

    Placebo

Study groups in NCT02338960
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; Drug: 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

    This score is on a scale ranging from 1.2 to 6. A higher score 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)

  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 (item 13).

    Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome.

    Higher scores indicate a worse 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 (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration

    Mean change from Baseline to end of study (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 indicates a better outcome.

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

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

    FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.

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

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

    FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

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

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

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

    Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)

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

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

    Female Sexual Function Index (FSFI) The score is computed programmatically ] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.

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

  6. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in 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 on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where 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 the Change in 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 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where 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 the Change in 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 FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement.

    A higher score on this scale 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 the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)

    Female Sexual Function Index (FSFI)

    The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher 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 the Change in 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. A higher number of events 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 the Change in 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

    The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.

    Measured: 24 weeks (Main Study)

  12. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the 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"). Decreased scores indicate improvement. A higher score indicates a worse outcome.

    Measured: 24 weeks (Main Study)

  13. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in 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 associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better 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 posted15 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2016
  4. Study completion29 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
714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02338960
Sponsor's protocol ID
BMT-302
Other IDs
Reconnect Study
Acronym
HSDD
Status last verified
Dec 2020
First submitted
12 Jan 2015
Last updated
28 Jan 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 28 Jan 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 28 Jan 2021). 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 NCT02338960, 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 28 Jan 2021.

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