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CompletedNCT01256684Updated Jun 26, 2017Results posted

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

A Phase 3 interventional study of Placebo and DHEA in Vaginal Atrophy, sponsored by EndoCeutics Inc.. Completed at 33 sites in 2 countries. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-26.

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

Phase
Phase 3
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study summary

The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with 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 255 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

Eligibility criteria

Main Inclusion Criteria:

  • women (hysterectomized or non-hysterectomized)
  • Women between 40 and 75 years of age.
  • Willing to participate in the study and sign an .
  • Women who have self-identified symptom(s)of vaginal atrophy.
  • For non-hysterectomized women, willing to have endometrial at screening and end of study.

Main Exclusion Criteria:

  • Undiagnosed abnormal genital bleeding.
  • Hypertension equal to or above 140/90 mm Hg.
  • The administration of any 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.
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.

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.

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.

05

Study design

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

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    0.25% DHEA

    Drug: DHEA

  • Experimental
    0.5% DHEA

    Drug: DHEA

Interventions

  • DrugPlacebo

    Placebo vaginal suppository

  • DrugDHEA

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

    Also known as: Prasterone, Dehydroepiandrosterone

  • DrugDHEA

    Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

    Also known as: Prasterone, Dehydroepiandrosterone

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

    The percentage of parabasal cell 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 the 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. Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

    The percentage of superficial cell 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 the 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. 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.

    Time frame: Baseline and Week 12

  4. 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.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 12

  2. 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 DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity

    To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness

    To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, 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 then 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

  5. 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 DHEA suppositories, 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 then analyzed using the 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 25, 2017

Participant flow

A total of 464 subjects were screened at 33 medical/research sites located in the US (24 centers) and Canada (9 centers) and 255 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 29-JUL-2011.

Participant flow — Overall Study
MilestonePlacebo0.25% DHEA0.50% DHEA
Started818787
Safety population808687
Itt population777981
Completed727476
Not completed91311
Withdrew: Adverse event142
Withdrew: Withdrawal by subject402
Withdrew: Physician decision010
Withdrew: Lack of efficacy011
Withdrew: Entry criteria not met/non-compliance476

Outcome measures

PrimaryChange From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

The percentage of parabasal cell 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 the 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
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Percentage of parabasal cellsPlacebo0.25% DHEA0.50% DHEA
Baseline68.48 ± 4.4165.72 ± 4.5665.05 ± 4.63
Week 1266.86 ± 4.3728.43 ± 3.6217.65 ± 2.87
Change from Baseline to Week 12-1.62 ± 3.22-37.29 ± 4.16-47.40 ± 4.72
PrimaryChange From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

The percentage of superficial cell 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 the 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
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Percentage of superficial cellsPlacebo0.25% DHEA0.50% DHEA
Baseline0.73 ± 0.150.68 ± 0.130.68 ± 0.12
Week 121.64 ± 0.335.43 ± 0.576.30 ± 0.59
Change from Baseline to Week 120.91 ± 0.314.75 ± 0.585.62 ± 0.61
PrimaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 in Vaginal pH
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline6.51 ± 0.076.48 ± 0.076.47 ± 0.07
Week 126.31 ± 0.095.70 ± 0.115.43 ± 0.10
Change from Baseline to Week 12-0.21 ± 0.08-0.77 ± 0.10-1.04 ± 0.11
PrimaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline2.58 ± 0.062.56 ± 0.062.63 ± 0.05
Week 121.71 ± 0.111.54 ± 0.121.36 ± 0.12
Change from Baseline to Week 12-0.87 ± 0.11-1.01 ± 0.11-1.27 ± 0.11
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline to Week 12 in Severity of Vaginal Dryness
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline2.33 ± 0.062.20 ± 0.052.37 ± 0.06
Week 121.32 ± 0.120.91 ± 0.100.92 ± 0.10
Change from Baseline to Week 12-1.02 ± 0.14-1.29 ± 0.11-1.45 ± 0.12
SecondaryChange 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 DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline2.78 ± 0.082.81 ± 0.072.83 ± 0.08
Week 122.36 ± 0.082.10 ± 0.091.95 ± 0.08
Change from Baseline to Week 12-0.42 ± 0.08-0.71 ± 0.09-0.88 ± 0.11
SecondaryChange 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 DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline2.58 ± 0.092.57 ± 0.102.57 ± 0.10
Week 122.13 ± 0.091.92 ± 0.091.69 ± 0.09
Change from Baseline to Week 12-0.45 ± 0.08-0.65 ± 0.09-0.88 ± 0.10
SecondaryChange 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 DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline2.91 ± 0.072.90 ± 0.082.89 ± 0.07
Week 122.57 ± 0.082.32 ± 0.092.14 ± 0.08
Change from Baseline to Week 12-0.34 ± 0.07-0.58 ± 0.09-0.75 ± 0.09
SecondaryChange 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 DHEA suppositories, 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 then analyzed using the 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
units on a scalePlacebo0.25% DHEA0.50% DHEA
Baseline2.82 ± 0.082.94 ± 0.082.94 ± 0.08
Week 122.56 ± 0.082.27 ± 0.102.05 ± 0.09
Change from Baseline to Week 12-0.26 ± 0.07-0.67 ± 0.09-0.89 ± 0.10

Adverse events

Collected over From Baseline up to 12 Weeks (+ 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—0/80 (0%)9/80 (11.3%)
0.25% DHEA—3/86 (3.5%)12/86 (14%)
0.50% DHEA—1/87 (1.1%)10/87 (11.5%)
Most frequent serious events
Most frequent serious events
EventPlacebo0.25% DHEA0.50% DHEA
Gastrointestinal haemorrhageGastrointestinal disorders0/801/860/87
Cholecystitis acuteHepatobiliary disorders0/801/860/87
Bone abscessInfections and infestations0/801/860/87
Thoracic vertebral fractureInjury, poisoning and procedural complications0/801/860/87
KyphosisMusculoskeletal and connective tissue disorders0/801/860/87
Suicidal ideationPsychiatric disorders0/800/861/87
Most frequent other events
Most frequent other events
EventPlacebo0.25% DHEA0.50% DHEA
Application site dischargeGeneral disorders5/806/865/87
Urinary tract infectionInfections and infestations4/806/865/87

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)Placebo0.25% DHEA0.50% DHEATotal
Mean58.81 ± 5.8959.37 ± 6.3957.51 ± 5.6358.55 ± 6.01
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Placebo0.25% DHEA0.50% DHEATotal
Female808687253
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo0.25% DHEA0.50% DHEATotal
White Caucasian698183233
Black or African American94316
Asian1012
Other1102
08

Study locations

33 sites
  • EndoCeutics site # 39
    Montgomery, Alabama 36117, United States
  • EndoCeutics site # 14
    Tucson, Arizona 85712, United States
  • EndoCeutics site # 21
    Sacramento, California 95821, United States
  • EndoCeutics site # 30
    San Diego, California 92108, United States
  • EndoCeutics site # 17
    San Diego, California 92120, United States
  • EndoCeutics site # 36
    Denver, Colorado 80218, United States
  • EndoCeutics site # 42
    Milford, Connecticut 06460, United States
  • EndoCeutics site # 45
    Boynton Beach, Florida 33472, United States
  • EndoCeutics site # 26
    Jacksonville, Florida 32207, United States
  • EndoCeutics site # 23
    Sandy Springs, Georgia 30328, United States
  • EndoCeutics site # 10
    Meridian, Idaho 83642, United States
  • EndoCeutics site # 27
    Baltimore, Maryland 21285-6815, United States
  • EndoCeutics site # 22
    Kalamazoo, Michigan 49009, United States
  • EndoCeutics site # 25
    Lincoln, Nebraska 68510, United States
  • EndoCeutics site # 28
    Moorestown, New Jersey 08057, United States
  • EndoCeutics site # 44
    New Brunswick, New Jersey 08901, United States
  • EndoCeutics site # 19
    New York, New York 10016, United States
  • EndoCeutics site # 16
    Durham, North Carolina 27713, United States
  • EndoCeutics site # 05
    Cleveland, Ohio 44122, United States
  • EndoCeutics site # 15
    Columbus, Ohio 43213, United States
  • EndoCeutics site # 35
    Pittsburgh, Pennsylvania 15206, United States
  • EndoCeutics site # 09
    West Jordan, Utah 84088, United States
  • EndoCeutics site # 31
    Charlottesville, Virginia 22903, United States
  • EndoCeutics site # 03
    Norfolk, Virginia 23507, United States
  • EndoCeutics site # 13
    Calgary, Alberta T2N 4L7, Canada
  • EndoCeutics site # 06
    Bathurst, New Brunswick E2A 4X7, Canada
  • EndoCeutics site # 04
    Drummondville, Quebec J2B 7T1, Canada
  • EndoCeutics site # 12
    Montreal, Quebec H4N 3C5, Canada
  • EndoCeutics site # 02
    Quebec City, Quebec G1S 2L6, Canada
  • EndoCeutics site # 01
    Quebec City, Quebec G1V 2L9, Canada
  • EndoCeutics site # 08
    Shawinigan, Quebec G9N 2H6, Canada
  • EndoCeutics site # 11
    Sherbrooke, Quebec J1H 1Z1, Canada
  • EndoCeutics site # 18
    St-Romuald, Quebec G6W 5M6, Canada
09

References and documents

Publications

  • Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428. PubMed 25734980 ↗
  • 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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2010, a primary completion of Aug 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2017, 5 years 8 months after primary completion. A results delay was requested in May 2013.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2010
First posted
Dec 8, 2010
Start
Dec 2010
Primary completionActual
Aug 2011
CompletionActual
Nov 2011
Results delay requested
May 1, 2013
Results first posted
Apr 25, 2017
Last update
Jun 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01256684
Lead sponsor
EndoCeutics Inc.
Responsible party
Sponsor
First posted
Dec 8, 2010
Start date
Dec 2010
Primary completion
Aug 2011
Completion
Nov 2011
Results posted
Apr 25, 2017
Last update
Jun 26, 2017

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dehydroepiandrosterone

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