Hypoactive Sexual Desire DisorderPhase 3NCT03287232
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
A Phase 3 study testing Prasterone 6.5 mg (0.50%) Vaginal Insert in people with Hypoactive Sexual Desire Disorder, run by EndoCeutics Inc. at 69 sites in 2 countries.
Trial summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Prasterone 6.5 mg (0.50%) Vaginal Insert
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 653 participants
- Where
- 69 sitesin 2 countries
- Study dates
- 16 Oct 2017to 22 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
69 sites in 2 countries.
69 sites in 2 countries
United States63 sites
Endoceutics site # 108
Berkeley, California, 84704
Endoceutics site # 101
Berlin, New Jersey, 08009
Endoceutics site # 127
Bluffton, South Carolina, 29910
Endoceutics site # 103
Boston, Massachusetts, 02131
Endoceutics site # 95
Bradenton, Florida, 34201
Endoceutics site # 116
Canton, Ohio, 44718
Endoceutics site # 96
Charlottesville, Virginia, 22942
Endoceutics site # 94
Chattanooga, Tennessee, 37404
Endoceutics site # 100
Cleveland, Ohio, 44106
Endoceutics site # 5
Cleveland, Ohio, 44122
Endoceutics site # 93
Columbus, Ohio, 43213
Endoceutics site # 120
Coral Gables, Florida, 33134
Endoceutics site # 107
Decatur, Georgia, 30030
Endoceutics site # 36
Denver, Colorado, 80209
Endoceutics site # 52
Denver, Colorado, 80220
Endoceutics site # 115
Fargo, North Dakota, 58103
Endoceutics site # 99
Fort Myers, Florida, 33912
Endoceutics site # 82
Houston, Texas, 77030
Endoceutics site # 106
Huntsville, Alabama, 35801
Endoceutics site # 64
Jackson, Tennessee, 38305
Endoceutics site # 26
Jacksonville, Florida, 32207
Endoceutics site # 22
Kalamazoo, Michigan, 49009
Endoceutics site #124
Knoxville, Tennessee, 37920
Endoceutics site # 60
Lake Worth, Florida, 33461
Endoceutics site # 88
Lexington, Kentucky, 40509
Endoceutics site # 121
Los Alamitos, California, 90720
Endoceutics site #128
Los Angeles, California, 90024
Endoceutics site # 86
Louisville, Kentucky, 40291
Endoceutics site #118
Miami Lakes, Florida, 33014
Endoceutics site # 104
Mobile, Alabama, 36608
Endoceutics site # 126
Mt. Pleasant, South Carolina, 29464
Endoceutics site # 112
Myrtle Beach, South Carolina, 29572
Endoceutics site #122
Nashville, Tennessee, 37203
Endoceutics site # 50
Neptune City, New Jersey, 07753
Endoceutics site # 44
New Brunswick, New Jersey, 08901
Endoceutics site # 125
New London, Connecticut, 06320
Endoceutics site # 20
New York, New York, 10016
Endoceutics site # 3
Norfolk, Virginia, 23507
Endoceutics site # 98
Norfolk, Virginia, 23507
Endoceutics site # 54
North Miami, Florida, 33161
Endoceutics site # 92
Oviedo, Florida, 32765
Endoceutics site # 75
Philadelphia, Pennsylvania, 19114
Endoceutics site # 81
Plainsboro, New Jersey, 08536
Endoceutics site # 123
Portsmouth, New Hampshire, 03801
Endoceutics site # 110
Poughkeepsie, New York, 12601
Endoceutics site # 58
Raleigh, North Carolina, 27612
Endoceutics site # 97
Rochester, New York, 14609
Endoceutics site # 119
Roswell, Georgia, 30075
Endoceutics site # 102
San Antonio, Texas, 78229
Endoceutics site # 30
San Diego, California, 92108
Endoceutics site # 17
San Diego, California, 92120
Endoceutics site # 23
Sandy Springs, Georgia, 30328
Endoceutics site # 105
Sanford, Florida, 32771
Endoceutics site # 91
Savannah, Georgia, 31406
Endoceutics site # 76
Seattle, Washington, 98105
Endoceutics site # 114
St. Petersburg, Florida, 33709
Endoceutics site # 117
Tucson, Arizona, 85712
Endoceutics site # 7
Washington D.C., District of Columbia, 20036
Endoceutics site # 89
West Palm Beach, Florida, 33401
Endoceutics site # 80
West Palm Beach, Florida, 33409
Endoceutics site # 90
West Palm Beach, Florida, 33409
Endoceutics site # 111
Wichita, Kansas, 67207
Endoceutics site # 55
Wichita, Kansas, 67226
Canada6 sites
Endoceutics site # 18
Lévis, Quebec, G6W 0M5
Endoceutics site # 02
Québec, Quebec, G1S 2L6
Endoceutics site # 77
Québec, Quebec, G1W 4R4
Endoceutics site # 78
Québec, Quebec, G3K 2P8
Endoceutics site # 68
Sarnia, Ontario, N7T 4X3
Endoceutics site # 11
Sherbrooke, Quebec, J1L 0H8
About this study
Official title: 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.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Placebo Vaginal Insert, Prasterone 6.5 mg (0.50%) Vaginal Insert
- Keywords
- Prasterone, DHEA, Menopause, Sexual Disorder
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Vaginal InsertDrug
Daily administration of a placebo vaginal insert.
Prasterone 6.5 mg (0.50%) Vaginal InsertDrug
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Vaginal Insert |
| Prasterone | Experimental | Not described Receives: Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual desire
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
Measured: 28 weeks
Distress from low sexual desire
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
Measured: 28 weeks
Secondary outcomes (1)
Satisfying sexual events (SSEs)
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start16 Oct 2017
- Primary completion8 Mar 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoCeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claude Labrie, M.D., Ph.D., Study chair, EndoCeutics Inc.Leonard R. Derogatis, Ph.D., Principal investigator, Maryland Center for Sexual Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287232
- Sponsor's protocol ID
- ERC-242
- Status last verified
- Apr 2021
- First submitted
- 15 Sep 2017
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.
PubMed 19424093Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
PubMed 26597311Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.
PubMed 26725467
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)
- ClinicalTrials.gov ID
- NCT03287232
- Acronym / sponsor ID
- ERC-242
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- Prasterone, DHEA, Menopause, Sexual Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- EndoCeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Vaginal Insert |
| Prasterone | Experimental | Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Vaginal InsertDaily administration of a placebo vaginal insert. | Drug | Placebo |
| Prasterone 6.5 mg (0.50%) Vaginal InsertDaily administration of a 6.5 mg (0.50%) prasterone vaginal insert. | Drug | Prasterone |
Primary outcome
Sexual desire
Time frame: 28 weeks
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
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.
1 secondary outcome
Satisfying sexual events (SSEs)
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Background: PubMed 19424093Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.
- Background: PubMed 26597311Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
- Background: PubMed 26725467Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.
- Individual participant dataSharing planned: No
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Labrie, M.D., Ph.D. study chair
EndoCeutics Inc.
Leonard R. Derogatis, Ph.D. principal investigator
Maryland Center for Sexual Health
69 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prasterone 6.5 mg (0.50%) Vaginal Insert in people with Hypoactive Sexual Desire Disorder, run by EndoCeutics Inc. at 69 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 5 inclusion and 5 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 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 69 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sexual desire (time frame: 28 weeks). 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 NCT03287232, which also lists 3 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; AzTrials last refreshed its copy on 7 Nov 2026.