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CompletedNCT01846442Updated Aug 29, 2017Results posted

Topical DHEA Against Vaginal Atrophy

A Phase 3 interventional study of Placebo and DHEA (0.25%) in Vaginal Atrophy, sponsored by EndoCeutics Inc.. Completed at 8 sites in 2 countries. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by EndoCeutics Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study summary

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

02

Conditions studied

  • Vaginal Atrophy

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Keywords

  • Vulvar/vaginal atrophy
  • Atrophic Vaginitis
  • Dehydroepiandrosterone
  • DHEA
  • Prasterone
  • Vaginorm
  • Menopause
  • Intrarosa
03

In context

Atrophic Vaginitis

45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.

This study's enrollment of 218 is above the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.

Browse Atrophic Vaginitis studies →

Lead sponsor

EndoCeutics Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women (non hysterectomized or hysterectomized)
  • Women between 40 and 75 years of age
  • Willing to participate in the study and sign an
  • Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
  • Women having a vaginal pH above 5
  • Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

Exclusion criteria

Exclusion Criteria:

  • Undiagnosed abnormal genital bleeding
  • Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
  • The administration of any drug within 30 days of screening visit
  • Endometrial hyperplasia at performed at screening or endometrial cancer
  • Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
218 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    0.25% DHEA

    Drug: DHEA (0.25%)

  • Experimental
    0.5% DHEA

    Drug: DHEA (0.5%)

  • Experimental
    1.0% DHEA

    Drug: DHEA (1.0%)

Interventions

  • DrugPlacebo

    Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.

    Also known as: Prasterone, Dehydroepiandrosterone

  • DrugDHEA (0.25%)

    Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.

    Also known as: Prasterone, Dehydroepiandrosterone

  • DrugDHEA (0.5%)

    Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

    Also known as: Prasterone, Dehydroepiandrosterone

  • DrugDHEA (1.0%)

    Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

    Also known as: Prasterone, Dehydroepiandrosterone

06

What researchers measure

Primary outcomes

  1. Co-primary Endpoint: Change From Baseline to Week 12 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 12 as well as the change from Baseline to Week 12 are presented.

    Time frame: Baseline and Week 12

  2. Co-primary Endpoint: Change From Baseline to Week 12 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 12 as well as the change from Baseline to Week 12 are presented.

    Time frame: Baseline and Week 12

  3. Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.

    A pH strip was applied directly to the lateral wall of the vagina using forceps. 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.

    Time frame: Baseline and Week 12

  4. Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome 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 12 as well as the change from Baseline to Week 12 are presented.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Change From Baseline to Week 12 of Vaginal Secretions

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

    Time frame: Baseline and Week 12

  2. Change From Baseline to Week 12 of Vaginal Epithelial Integrity

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

    Time frame: Baseline and Week 12

  3. Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

    Time frame: Baseline and Week 12

  4. Change From Baseline to Week 12 of Vaginal Color

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

    Time frame: Baseline and Week 12

07

Results

Posted Apr 28, 2017

Participant flow

A total of 403 subjects were screened at 8 medical/research sites located in the US (2 centers) and Canada (6 centers) and 218 subjects were randomized. The first subject first visit was on 28-JUN-2007 and the last subject last visit was on 23-MAY-2008.

Participant flow — Overall Study
MilestonePlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Started54545654
Safety population54535654
Itt population53535654
Completed48485251
Not completed6643
Withdrew: Adverse event2421
Withdrew: Lost to follow-up0010
Withdrew: Withdrawal by subject3201
Withdrew: Left the city/lost medication1011

Outcome measures

PrimaryCo-primary Endpoint: Change From Baseline to Week 12 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 12 as well as the change from Baseline to Week 12 are presented.

Time frame:
Baseline and Week 12
Reported as:
Mean · percentage of parabasal cells
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)
percentage of parabasal cellsPlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline46.7 ± 8.6465.5 ± 6.9253.4 ± 7.4961.8 ± 6.88
Week 1247.8 ± 7.5216.9 ± 3.6611.0 ± 3.436.90 ± 1.77
Change from Baseline1.1 ± 3.62-48.6 ± 6.78-42.4 ± 7.36-54.9 ± 6.60
PrimaryCo-primary Endpoint: Change From Baseline to Week 12 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 12 as well as the change from Baseline to Week 12 are presented.

Time frame:
Baseline and Week 12
Reported as:
Mean · percentage of superficial cells
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)
percentage of superficial cellsPlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline0.6 ± 0.20.4 ± 0.150.4 ± 0.110.4 ± 0.16
Week 120.5 ± 0.195.7 ± 1.335.2 ± 1.196.5 ± 1.53
Change from Baseline-0.1 ± 0.235.3 ± 1.394.8 ± 1.206.1 ± 1.54
PrimaryCo-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.

A pH strip was applied directly to the lateral wall of the vagina using forceps. 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · pH
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
pHPlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline6.5 ± 0.136.6 ± 0.106.6 ± 0.096.5 ± 0.11
Week 126.0 ± 0.225.5 ± 0.195.2 ± 0.175.1 ± 0.12
Change from Baseline-0.5 ± 0.16-1.1 ± 0.16-1.5 ± 0.18-1.4 ± 0.15
PrimaryCo-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome 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 12 as well as the change from Baseline to Week 12 are presented.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
units on a scalePlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline2.8 ± 0.082.8 ± 0.082.7 ± 0.082.6 ± 0.09
Week 122.3 ± 0.181.4 ± 0.221.1 ± 0.221.2 ± 0.20
Change from Baseline-0.4 ± 0.16-1.3 ± 0.20-1.6 ± 0.21-1.4 ± 0.18
SecondaryChange From Baseline to Week 12 of Vaginal Secretions

To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 of Vaginal Secretions
units on a scalePlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline3.1 ± 0.093.1 ± 0.093.2 ± 0.093.0 ± 0.08
Week 122.7 ± 0.121.9 ± 0.101.8 ± 0.121.5 ± 0.09
Change from Baseline-0.4 ± 0.10-1.2 ± 0.12-1.4 ± 0.13-1.4 ± 0.11
SecondaryChange From Baseline to Week 12 of Vaginal Epithelial Integrity

To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 of Vaginal Epithelial Integrity
units on a scalePlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline2.8 ± 0.132.7 ± 0.122.8 ± 0.112.7 ± 0.11
Week 122.4 ± 0.131.7 ± 0.111.5 ± 0.101.4 ± 0.09
Change from Baseline-0.4 ± 0.12-1.0 ± 0.14-1.3 ± 0.12-1.3 ± 0.11
SecondaryChange From Baseline to Week 12 of Vaginal Epithelial Surface Thickness

To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
units on a scalePlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline3.0 ± 0.102.9 ± 0.083.1 ± 0.093.0 ± 0.08
Week 122.6 ± 0.121.9 ± 0.111.8 ± 0.111.6 ± 0.10
Change from Baseline-0.4 ± 0.10-1.0 ± 0.12-1.3 ± 0.12-1.4 ± 0.12
SecondaryChange From Baseline to Week 12 of Vaginal Color

To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 of Vaginal Color
units on a scalePlacebo0.25% DHEA0.50% DHEA1.00% DHEA
Baseline3.1 ± 0.093.0 ± 0.103.1 ± 0.093.1 ± 0.07
Week 122.7 ± 0.112.0 ± 0.121.8 ± 0.111.6 ± 0.10
Change from Baseline-0.5 ± 0.11-1.0 ± 0.13-1.3 ± 0.14-1.5 ± 0.12

Adverse events

Collected over From Baseline to Week 12 (+ 30-day follow-up period after last dose). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/54 (0%)34/54 (63%)
0.25% DHEA—1/53 (1.9%)32/53 (60.4%)
0.50% DHEA—1/56 (1.8%)46/56 (82.1%)
1.00% DHEA—0/54 (0%)39/54 (72.2%)
Most frequent serious events
Most frequent serious events
EventPlacebo0.25% DHEA0.50% DHEA1.00% DHEA
CholecystectomySurgical and medical procedures0/541/530/560/54
AppendicetomySurgical and medical procedures0/540/531/560/54
Most frequent other events
Most frequent other events
EventPlacebo0.25% DHEA0.50% DHEA1.00% DHEA
CoughRespiratory, thoracic and mediastinal disorders2/542/537/561/54
HeadacheNervous system disorders3/546/536/564/54
NasopharyngitisInfections and infestations5/546/534/564/54
Vaginal dischargeReproductive system and breast disorders3/544/536/562/54
Abdominal painGastrointestinal disorders4/542/533/565/54
Back painMusculoskeletal and connective tissue disorders5/542/534/565/54
FatigueGeneral disorders1/543/534/565/54
Vulvovaginal pruritusReproductive system and breast disorders3/544/535/565/54
Hot flushReproductive system and breast disorders4/542/534/564/54
Vulvovaginal burning sensationReproductive system and breast disorders4/541/533/564/54

Baseline characteristics

Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of prasterone or placebo, and who have any safety information available.

Age, Continuous
Age, Continuous(years)Placebo0.25% DHEA0.50% DHEA1.00% DHEATotal
Mean59.00 ± 5.4057.68 ± 6.3158.45 ± 5.5559.44 ± 4.6358.65 ± 5.50
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Placebo0.25% DHEA0.50% DHEA1.00% DHEATotal
Female54535654217
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo0.25% DHEA0.50% DHEA1.00% DHEATotal
White Caucasian50515453208
Black or African American00000
Asian31116
Other11103
08

Study locations

8 sites
  • EndoCeutics site # 05
    Cleveland, Ohio 44122, United States
  • EndoCeutics site # 03
    Norfolk, Virginia 23507, United States
  • EndoCeutics site # 10
    Montreal, Quebec H1T 1P6, Canada
  • EndoCeutics site # 09
    Montreal, Quebec H3A 1A1, Canada
  • EndoCeutics site # 08
    Shawinigan, Quebec G9N 2H6, Canada
  • EndoCeutics site # 11
    Sherbrooke, Quebec J1H 1Z1, Canada
  • EndoCeutics site # 02
    Quebec, G1S 2L6, Canada
  • EndoCeutics site # 01
    Quebec, G1V 4G2, Canada
09

References and documents

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, Berube R, Belanger P, Berger L, Gilbert L, Martel C, Balser J. Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration. Menopause. 2009 Sep-Oct;16(5):897-906. doi: 10.1097/gme.0b013e31819e8930. PubMed 19436226 ↗
  • 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. Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy. Menopause. 2009 Sep-Oct;16(5):907-22. doi: 10.1097/gme.0b013e31819e8e2d. PubMed 19436225 ↗
  • 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 19424093 ↗
  • 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, Martel C, Balser J. High internal consistency and efficacy of intravaginal DHEA for vaginal atrophy. Gynecol Endocrinol. 2010 Jul;26(7):524-32. doi: 10.3109/09513590903511547. PubMed 20459349 ↗
  • Labrie F, Archer DF, 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. Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia. Climacteric. 2011 Apr;14(2):282-8. doi: 10.3109/13697137.2010.535226. Epub 2011 Jan 18. PubMed 21244215 ↗
  • 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, Gilbert L, Martel C, Balser J. Lack of influence of dyspareunia on the beneficial effect of intravaginal prasterone (dehydroepiandrosterone, DHEA) on sexual dysfunction in postmenopausal women. J Sex Med. 2014 Jul;11(7):1766-85. doi: 10.1111/jsm.12517. Epub 2014 Apr 28. PubMed 24774442 ↗
  • 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 ↗
  • Labrie F. Intravaginal DHEA, by a strictly local action, exerts beneficial effects on both vaginal atrophy symptoms and sexual dysfunction. Horm Mol Biol Clin Investig. 2010 Dec 1;4(1):499-507. doi: 10.1515/HMBCI.2010.064. PubMed 25961226 ↗
  • 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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01846442
Lead sponsor
EndoCeutics Inc.
Responsible party
Sponsor
First posted
May 3, 2013
Start date
Jun 2007
Primary completion
May 2008
Completion
Oct 2008
Results posted
Apr 28, 2017
Last update
Aug 29, 2017

Study contacts

David F Archer, MD
principal investigator · Clinical Research Center, Eastern Virginia Medical Scholl, Norfolk, VA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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