Hypoactive Sexual Desire Disorder (HSDD)Phase 3NCT03619005
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study
A Phase 3 study testing Prasterone 6.5 mg (0.50%) Vaginal Insert in people with Hypoactive Sexual Desire Disorder (HSDD), run by EndoCeutics Inc. at 10 sites in United States.
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 (HSDD)
- 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
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Nov 2018to 6 Dec 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Endoceutics site # 127
Bluffton, South Carolina, 29910
Endoceutics site # 115
Fargo, North Dakota, 58103
Endoceutics site # 106
Huntsville, Alabama, 35801
Endoceutics site # 125
New London, Connecticut, 06320
Endoceutics site # 20
New York, New York, 10016
Endoceutics site # 119
Roswell, Georgia, 30075
Endoceutics site # 102
San Antonio, Texas, 78229
Endoceutics site # 17
San Diego, California, 92120
Endoceutics site # 91
Savannah, Georgia, 31406
Endoceutics site # 114
St. Petersburg, Florida, 33709
About this study
Official title: Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (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 (HSDD)
- Being tested
- Placebo Vaginal Insert, Prasterone 6.5 mg (0.50%) Vaginal Insert
- Keywords
- Prasterone, DHEA, Menopause, Sexual Disorder, HSDD
- 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 | Active comparator | 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 as evaluated by Questions 1 \& 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 \& 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.
Measured: 28 weeks
Distress from low sexual desire
Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.
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 posted7 Aug 2018
- Study start13 Nov 2018
- Primary completion15 Aug 2019
- Study completion6 Dec 2019
Why it stopped: Business decision to not continue this study (only few subjects were screened).
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 Disorder (HSDD)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoCeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Claude Labrie, M.D., Ph.D., Study chair, EndoCeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619005
- Sponsor's protocol ID
- ERC-245
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2018
- Last updated
- 31 Jul 2020
- 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 31 Jul 2020. 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) - Second Study (Placebo-Controlled, Double-Blind and Randomized Phase III Study of Intravaginal Prasterone)
- ClinicalTrials.gov ID
- NCT03619005
- Acronym / sponsor ID
- ERC-245
- Conditions
- Hypoactive Sexual Desire Disorder (HSDD)
- Keywords
- Prasterone, DHEA, Menopause, Sexual Disorder, HSDD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision to not continue this study (only few subjects were screened).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EndoCeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 7 Aug 2018 (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 | Active comparator | 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 as evaluated by Questions 1 \& 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 \& 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.
Distress from low sexual desire
Time frame: 28 weeks
Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.
1 secondary outcome
Satisfying sexual events (SSEs)
Time frame: 28 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- 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 (HSDD)
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.
10 sites in 1 country: 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 (HSDD), run by EndoCeutics Inc. at 10 sites in United States.
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: withdrawn, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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 NCT03619005, 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 31 Jul 2020.