Vaginal AtrophyPhase 3NCT02013544

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

A Phase 3 study testing Prasterone (DHEA) in people with Vaginal Atrophy, run by EndoCeutics Inc. at 38 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

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements. Read more about this study

Who is it for?: Ages 40 to 80 years, women only
Conditions the study is for: Vaginal Atrophy
What is being tested?: Prasterone (DHEA)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 558 participants
Where: 38 sitesin 2 countries
Study dates: Feb 2014to Feb 2015
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 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Main criteria:
Postmenopausal women (hysterectomized or not)
Women between 40 and 80 years of age
Women having ≤5% of superficial cells on vaginal smear at baseline
Women having a vaginal pH above 5 at baseline
Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
Willing to participate in the study and sign an informed consent

Who cannot join

Main criteria:
Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
Previous diagnosis of cancer, except skin cancer (non melanoma)
Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
The administration of any investigational drug within 30 days of screening visit
Clinically significant abnormal serum biochemistry, urinalysis or hematology

Trial locations and contacts

38 sites in 2 countries.

Country

City, postcode or hospital

38 sites in 2 countries

United States24 sites

EndoCeutics site # 23
Atlanta, Georgia, 30328
EndoCeutics site # 45
Boynton Beach, Florida, 33472
EndoCeutics site # 05
Cleveland, Ohio, 44122
EndoCeutics site # 15
Columbus, Ohio, 43213
EndoCeutics site # 84
Corpus Christi, Texas, 78414
EndoCeutics site # 36
Denver, Colorado, 80209
EndoCeutics site # 52
Denver, Colorado, 80220
EndoCeutics site # 82
Houston, Texas, 77030
EndoCeutics site # 60
Lake Worth, Florida, 33461
EndoCeutics site # 87
Lawrenceville, New Jersey, 08648
EndoCeutics site # 86
Louisville, Kentucky, 40291
EndoCeutics site # 27
Lutherville, Maryland, 21093
EndoCeutics site # 39
Montgomery, Alabama, 36117
EndoCeutics site # 03
Norfolk, Virginia, 23507
EndoCeutics site # 54
North Miami, Florida, 33161
EndoCeutics site # 75
Philadelphia, Pennsylvania, 19114-1029
EndoCeutics site # 81
Plainsboro, New Jersey, 08536
EndoCeutics site # 21
Sacramento, California, 95821
EndoCeutics site # 83
San Diego, California, 92103
EndoCeutics site # 30
San Diego, California, 92108
EndoCeutics site # 76
Seattle, Washington, 98105
EndoCeutics site # 14
Tucson, Arizona, 85712
EndoCeutics site # 80
West Palm Beach, Florida, 33409
EndoCeutics site # 55
Wichita, Kansas, 67226

Other trials in United States

Canada14 sites

EndoCeutics site # 85
Burlington, Ontario, L7R 4B8
EndoCeutics site # 69
Corunna, Ontario, N0N1G0
EndoCeutics site # 04
Drummondville, Quebec, J2B 7T1
EndoCeutics site # 12
Montreal, Quebec, H4N 3C5
EndoCeutics site # 79
Pointe-Claire, Quebec, H9R 4S3
EndoCeutics site # 02
Québec, Quebec, G1S 2L6
EndoCeutics site # 01
Québec, Quebec, G1V 2L9
EndoCeutics site # 77
Québec, Quebec, G1W 4R4
EndoCeutics site # 78
Québec, Quebec, G3K 2P8
EndoCeutics site # 18
Saint Romuald, Quebec, G6W 5M6
EndoCeutics site # 68
Sarnia, Ontario, N7T 4X3
EndoCeutics site # 74
Sherbrooke, Quebec, J1J 2G2
EndoCeutics site # 67
Victoriaville, Quebec, G6P 6P6
EndoCeutics site # 73
Waterloo, Ontario, N2J 1C4

Other trials in Canada

About this study

Conditions: Vaginal Atrophy
Being tested: Placebo, Prasterone (DHEA)
Keywords: Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, prasterone, DHEA, 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.

PlaceboDrug
Prasterone (DHEA)Drug

Study groups in NCT02013544
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo vaginal ovule daily for 12 weeks Receives: Drug: Placebo
Prasterone	Experimental	Prasterone (DHEA) vaginal ovule daily for 12 weeks Receives: Drug: Prasterone (DHEA)

What is being measured

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

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
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 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
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 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in 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 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire filled out by women. 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 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12

Secondary outcomes (5)

Change From Baseline to Week 12 in Severity of Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. 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 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Measured: Baseline and Week 12

Timeline

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

Feb 2014Feb 2015

First posted17 Dec 2013 (estimated)
Study startFeb 2014
Primary completionJan 2015
Study completionFeb 2015

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 (6)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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 558 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02013544
Sponsor's protocol ID: ERC-238
Status last verified: May 2017
First submitted: 9 Dec 2013
Last updated: 1 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.
PubMed 26291918
Labrie 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 26597311
Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.
PubMed 26517756
Labrie F, 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; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
PubMed 26731686
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
Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.
PubMed 26634942

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 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
ClinicalTrials.gov ID: NCT02013544
Acronym / sponsor ID: ERC-238
Conditions: Vaginal Atrophy
Keywords: Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, prasterone, DHEA, Intrarosa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 558 participants (actual)
Lead sponsor: EndoCeutics Inc.Industry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 17 Dec 2013 (estimated)
Results: Posted 1 Jun 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: 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: PlaceboPlacebo vaginal ovule daily for 12 weeks
Prasterone	Experimental	Drug: Prasterone (DHEA)Prasterone (DHEA) vaginal ovule daily for 12 weeks

Who may qualify

Ages: 40 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Postmenopausal women (hysterectomized or not)
Women between 40 and 80 years of age
Women having ≤5% of superficial cells on vaginal smear at baseline
Women having a vaginal pH above 5 at baseline
Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

Key exclusion criteria (6 listed)

Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
Previous diagnosis of cancer, except skin cancer (non melanoma)
Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
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	Drug	Placebo
Prasterone (DHEA)	Drug	Prasterone

Primary outcome

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Time frame: Baseline and Week 12
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 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Time frame: Baseline and Week 12
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 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Vaginal pH
Time frame: Baseline and Week 12
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 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
Time frame: Baseline and Week 12
The severity of dyspareunia was evaluated by a questionnaire filled out by women. 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 12 as well as the change from Baseline to Week 12 are presented.

5 secondary outcomes

Change From Baseline to Week 12 in Severity of Vaginal Dryness
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 1 Jun 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
Placebo	182	171
0.50% Prasterone (DHEA)	376	356

Primary outcome: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: Percentage of superficial cells

Measure	Placebo n = 157	0.50% Prasterone (DHEA) n = 325
Baseline	1.04 (0.11)	1.02 (0.08)
Week 12	2.78 (0.27)	11.22 (0.56)
Change from Baseline to Week 12	1.75 (0.27)	10.20 (0.57)

Population analysed: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.

Primary outcome: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: Percentage of parabasal cells

Measure	Placebo n = 157	0.50% Prasterone (DHEA) n = 325
Baseline	51.66 (3.00)	54.25 (2.14)
Week 12	39.68 (2.68)	12.74 (1.02)
Change from Baseline to Week 12	-11.98 (2.36)	-41.51 (2.01)

Primary outcome: Change From Baseline to Week 12 in Vaginal pH

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 157	0.50% Prasterone (DHEA) n = 325
Baseline	6.32 (0.05)	6.34 (0.04)
Week 12	6.05 (0.07)	5.39 (0.05)
Change from Baseline to Week 12	-0.27 (0.06)	-0.94 (0.05)

Primary outcome: Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 157	0.50% Prasterone (DHEA) n = 325
Baseline	2.56 (0.04)	2.54 (0.03)
Week 12	1.50 (0.08)	1.13 (0.05)
Change from Baseline to Week 12	-1.06 (0.08)	-1.42 (0.06)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to Week 12 (+ 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
Placebo	0 of 180 (0%)	10 of 180 (5.6%)	Not reported
0.50% Prasterone (DHEA)	5 of 374 (1.3%)	24 of 374 (6.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26291918Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.
Results publication: 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.
Results publication: PubMed 26517756Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.
Results publication: PubMed 26731686Labrie F, 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; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
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.
Results publication: PubMed 26634942Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.

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)
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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.

Fernand Labrie, M.D., Ph.D. study chair

EndoCeutics Inc.

David F Archer, M.D. principal investigator

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

38 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 (DHEA) in people with Vaginal Atrophy, run by EndoCeutics Inc. at 38 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 7 inclusion and 6 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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 1 Jun 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?

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear (time frame: Baseline and Week 12). The study lists 4 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 NCT02013544, which also lists 6 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 1 Jun 2017.