Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

April 7, 2021 updated by: EndoCeutics Inc.

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
653

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • EndoCeutics site # 68
    • Quebec
      • Lévis, Quebec, Canada, G6W 0M5
        • EndoCeutics site # 18
      • Québec, Quebec, Canada, G1S 2L6
        • EndoCeutics site # 02
      • Québec, Quebec, Canada, G1W 4R4
        • EndoCeutics site # 77
      • Québec, Quebec, Canada, G3K 2P8
        • EndoCeutics site # 78
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • EndoCeutics site # 11
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Endoceutics site # 106
      • Mobile, Alabama, United States, 36608
        • Endoceutics site # 104
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Endoceutics site # 117
    • California
      • Berkeley, California, United States, 84704
        • Endoceutics site # 108
      • Los Alamitos, California, United States, 90720
        • Endoceutics site # 121
      • Los Angeles, California, United States, 90024
        • Endoceutics site #128
      • San Diego, California, United States, 92108
        • EndoCeutics site # 30
      • San Diego, California, United States, 92120
        • EndoCeutics site # 17
    • Colorado
      • Denver, Colorado, United States, 80209
        • EndoCeutics site # 36
      • Denver, Colorado, United States, 80220
        • EndoCeutics site # 52
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Endoceutics site # 125
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • Endoceutics site # 7
    • Florida
      • Bradenton, Florida, United States, 34201
        • Endoceutics site # 95
      • Coral Gables, Florida, United States, 33134
        • Endoceutics site # 120
      • Fort Myers, Florida, United States, 33912
        • Endoceutics site # 99
      • Jacksonville, Florida, United States, 32207
        • EndoCeutics site # 26
      • Lake Worth, Florida, United States, 33461
        • EndoCeutics site # 60
      • Miami Lakes, Florida, United States, 33014
        • Endoceutics site #118
      • North Miami, Florida, United States, 33161
        • EndoCeutics site # 54
      • Oviedo, Florida, United States, 32765
        • Endoceutics site # 92
      • Saint Petersburg, Florida, United States, 33709
        • Endoceutics site # 114
      • Sanford, Florida, United States, 32771
        • Endoceutics site # 105
      • West Palm Beach, Florida, United States, 33401
        • Endoceutics site # 89
      • West Palm Beach, Florida, United States, 33409
        • EndoCeutics site # 80
      • West Palm Beach, Florida, United States, 33409
        • Endoceutics site # 90
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Endoceutics site # 107
      • Roswell, Georgia, United States, 30075
        • Endoceutics site # 119
      • Sandy Springs, Georgia, United States, 30328
        • EndoCeutics site # 23
      • Savannah, Georgia, United States, 31406
        • Endoceutics site # 91
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Endoceutics site # 111
      • Wichita, Kansas, United States, 67226
        • EndoCeutics site # 55
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Endoceutics site # 88
      • Louisville, Kentucky, United States, 40291
        • EndoCeutics site # 86
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Endoceutics site # 103
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • EndoCeutics site # 22
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Endoceutics site # 123
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Endoceutics site # 101
      • Neptune, New Jersey, United States, 07753
        • EndoCeutics site # 50
      • New Brunswick, New Jersey, United States, 08901
        • EndoCeutics site # 44
      • Plainsboro, New Jersey, United States, 08536
        • EndoCeutics site # 81
    • New York
      • New York, New York, United States, 10016
        • Endoceutics site # 20
      • Poughkeepsie, New York, United States, 12601
        • Endoceutics site # 110
      • Rochester, New York, United States, 14609
        • Endoceutics site # 97
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Endoceutics site # 58
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Endoceutics site # 115
    • Ohio
      • Canton, Ohio, United States, 44718
        • Endoceutics site # 116
      • Cleveland, Ohio, United States, 44106
        • Endoceutics site # 100
      • Cleveland, Ohio, United States, 44122
        • Endoceutics site # 5
      • Columbus, Ohio, United States, 43213
        • Endoceutics site # 93
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • EndoCeutics site # 75
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Endoceutics site # 127
      • Mount Pleasant, South Carolina, United States, 29464
        • Endoceutics site # 126
      • Myrtle Beach, South Carolina, United States, 29572
        • Endoceutics site # 112
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Endoceutics site # 94
      • Jackson, Tennessee, United States, 38305
        • EndoCeutics site # 64
      • Knoxville, Tennessee, United States, 37920
        • Endoceutics site #124
      • Nashville, Tennessee, United States, 37203
        • Endoceutics site #122
    • Texas
      • Houston, Texas, United States, 77030
        • EndoCeutics site # 82
      • San Antonio, Texas, United States, 78229
        • Endoceutics site # 102
    • Virginia
      • Charlottesville, Virginia, United States, 22942
        • Endoceutics site # 96
      • Norfolk, Virginia, United States, 23507
        • Endoceutics site # 3
      • Norfolk, Virginia, United States, 23507
        • Endoceutics site # 98
    • Washington
      • Seattle, Washington, United States, 98105
        • EndoCeutics site # 76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria (main criteria):

  • Postmenopausal women (hysterectomized or not).
  • Women between 40 and 80 years of age.
  • Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.
  • Diagnosis of HSDD confirmed by a qualified clinician.
  • Willing to participate in the study and sign an informed consent.

Exclusion Criteria (main criteria):

  • Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.
  • Taking drugs which could be responsible for HSDD.
  • Severe medical condition which can explain the loss of sexual desire.
  • The administration of any investigational drug within 30 days of screening visit.
  • Clinically significant abnormal serum biochemistry, urinalysis or hematology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo Vaginal Insert
Daily administration of a placebo vaginal insert.
Experimental: Prasterone
Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual desire
Time Frame: 28 weeks
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).
28 weeks
Distress from low sexual desire
Time Frame: 28 weeks
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
28 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfying sexual events (SSEs)
Time Frame: 28 weeks
Change from Baseline in the number of SSEs from a daily log of sexual activity.
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EndoCeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Claude Labrie, M.D., Ph.D., EndoCeutics Inc.
  • Principal Investigator: Leonard R. Derogatis, Ph.D., Maryland Center for Sexual Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERC-242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoactive Sexual Desire Disorder

Clinical Trials on Placebo Vaginal Insert

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings