Vaginal AtrophyPhase 3NCT01256671

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

A Phase 3 study testing DHEA in people with Vaginal Atrophy, run by EndoCeutics Inc. at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years. Read more about this study

Who is it for?: Ages 40 to 75 years, women only
Conditions the study is for: Vaginal Atrophy
What is being tested?: DHEA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 530 participants
Where: 41 sitesin 2 countries
Study dates: Dec 2010to Dec 2012
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 40 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Postmenopausal women (non-hysterectomized)
Women between 40 and 75 years of age.
Willing to participate in the study and sign an informed consent.
Women who have self-identified symptom(s) of vaginal atrophy.
Willing to have endometrial biopsy at screening and end of study (Week 52).

Main Exclusion Criteria:

Undiagnosed abnormal genital bleeding.
Hypertension equal to or above 140/90 mm Hg.
The administration of any investigational drug within 30 days of screening visit.
Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Trial locations and contacts

41 sites in 2 countries.

Country

City, postcode or hospital

41 sites in 2 countries

United States31 sites

EndoCeutics site # 27
Baltimore, Maryland, 21285-6815
EndoCeutics site # 33
Beachwood, Ohio, 44122
EndoCeutics site # 45
Boynton Beach, Florida, 33472
EndoCeutics site # 31
Charlottesville, Virginia, 22903
EndoCeutics site # 05
Cleveland, Ohio, 44122
EndoCeutics site # 47
Cleveland, Ohio, 44124
EndoCeutics site # 15
Columbus, Ohio, 43213
EndoCeutics site # 36
Denver, Colorado, 80218
EndoCeutics site # 16
Durham, North Carolina, 27713
EndoCeutics site # 26
Jacksonville, Florida, 32207
EndoCeutics site # 22
Kalamazoo, Michigan, 49009
EndoCeutics site # 25
Lincoln, Nebraska, 68510
EndoCeutics site # 10
Meridian, Idaho, 83642
EndoCeutics site # 42
Milford, Connecticut, 06460
EndoCeutics site # 39
Montgomery, Alabama, 36117
EndoCeutics site # 28
Moorestown, New Jersey, 08057
EndoCeutics site # 50
Neptune City, New Jersey, 07753
EndoCeutics site # 44
New Brunswick, New Jersey, 08901
EndoCeutics site # 19
New York, New York, 10016
EndoCeutics site # 03
Norfolk, Virginia, 23507
EndoCeutics site # 24
Omaha, Nebraska, 68131
EndoCeutics site # 35
Pittsburgh, Pennsylvania, 15206
EndoCeutics site # 38
Renton, Washington, 98055
EndoCeutics site # 21
Sacramento, California, 95821
EndoCeutics site # 30
San Diego, California, 92108
EndoCeutics site # 17
San Diego, California, 92120
EndoCeutics site # 23
Sandy Springs, Georgia, 30328
EndoCeutics site # 14
Tucson, Arizona, 85712
EndoCeutics site # 07
Washington D.C., District of Columbia, 20036
EndoCeutics site # 09
West Jordan, Utah, 84088
EndoCeutics site # 41
West Palm Beach, Florida, 33401

Other trials in United States

Canada10 sites

EndoCeutics site # 06
Bathurst, New Brunswick, E2A 4X7
EndoCeutics site # 13
Calgary, Alberta, T2N 4L7
EndoCeutics site # 04
Drummondville, Quebec, J2B 7T1
EndoCeutics site # 34
Montreal, Quebec, H2X 3J4
EndoCeutics site # 12
Montreal, Quebec, H4N 3C5
EndoCeutics site # 02
Québec, Quebec, G1S 2L6
EndoCeutics site # 01
Québec, Quebec, G1V 2L9
EndoCeutics site # 18
Saint Romuald, Quebec, G6W 5M6
EndoCeutics site # 08
Shawinigan, Quebec, G9N 2H6
EndoCeutics site # 11
Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

About this study

Conditions: Vaginal Atrophy
Being tested: DHEA
Keywords: Vulvar/Vaginal Atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
Medical subject headings: Atrophic Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DHEADrug
Also called Prasterone, Dehydroepiandrosterone, Vaginorm
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

Study groups in NCT01256671
Study group	Role	What they receive
DHEA	Experimental	0.5% DHEA (intravaginal) Receives: Drug: DHEA

What is being measured

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

Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
Measured: Baseline and Week 52 (or discontinuation)
Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52

Secondary outcomes (6)

Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52
Change From Baseline to Week 52 of Vaginal pH.
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching
The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Measured: Baseline and Week 52

Timeline

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

Dec 2010Dec 2012

First posted8 Dec 2010 (estimated)
Study startDec 2010
Primary completionJul 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Vaginal AtrophyStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256671
Sponsor's protocol ID: ERC-230
Status last verified: Sep 2017
First submitted: 3 Dec 2010
Last updated: 18 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Cote I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur E; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.
PubMed 25771041
Bouchard 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
Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035.
PubMed 26509785
Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470.
PubMed 25968836
Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.
PubMed 26972555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms

All Vaginal Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DHEA Against Vaginal Atrophy - Safety Study of 12 Months
ClinicalTrials.gov ID: NCT01256671
Acronym / sponsor ID: ERC-230
Conditions: Vaginal Atrophy
Keywords: Vulvar/Vaginal Atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: EndoCeutics Inc.Industry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Jul 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 18 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DHEA	Experimental	Drug: DHEA0.5% DHEA (intravaginal)

Who may qualify

Ages: 40 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
DHEAAlso: Prasterone, Dehydroepiandrosterone, VaginormVaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.	Drug	DHEA

Primary outcome

Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
Time frame: Baseline and Week 52 (or discontinuation)
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
Time frame: Baseline and Week 52
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.

6 secondary outcomes

Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).
Time frame: Baseline and Week 52
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).
Time frame: Baseline and Week 52
Change From Baseline to Week 52 of Vaginal pH.
Time frame: Baseline and Week 52
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia
Time frame: Baseline and Week 52
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness
Time frame: Baseline and Week 52
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching
Time frame: Baseline and Week 52

Results and safety

Results posted to the registry on 18 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.50% DHEA	530	435

Primary outcome: Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium

Time frame: Baseline and Week 52 (or discontinuation). Count of participants. Unit: Participants

Measure	0.50% DHEA n = 457
Endometrium: Atrophic/Inactive	421
Endometrium: No/Insufficient Tissue for Diagnosis	36

Population analysed: Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis.

Primary outcome: Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels

Time frame: Baseline and Week 52. Mean (Standard Error). Unit: pg/mL

Measure	0.50% DHEA n = 429
DHEA: Baseline	2071.61 (65.70)
DHEA: Week 52	2997.25 (85.23)
DHEA: Change from Baseline	925.65 (74.35)
E2: Baseline	6.05 (1.11)
E2: Week 52	4.46 (0.32)
E2: Change from Baseline	-1.59 (1.13)
TESTO: Baseline	161.28 (6.93)
TESTO: Week 52	189.44 (4.79)

Population analysed: Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to Week 52 (+ 30-day follow-up period after last dose). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.50% DHEA	18 of 521 (3.5%)	177 of 521 (34%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25771041Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Cote I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur E; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.
Results publication: 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.
Results publication: PubMed 26509785Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035.
Results publication: PubMed 25968836Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470.
Results publication: PubMed 26972555Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.

Related trials for Vaginal Atrophy

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms

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.

David F Archer, MD principal investigator

Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

41 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 DHEA in people with Vaginal Atrophy, run by EndoCeutics Inc. at 41 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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. 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 18 Oct 2017). 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?

Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium (time frame: Baseline and Week 52 (or discontinuation)). 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 NCT01256671, which also lists 5 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 18 Oct 2017.