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CompletedNCT01358760Updated Jun 12, 2017Results posted

Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

A Phase 3 interventional study of Placebo and DHEA in Vaginal Atrophy, sponsored by EndoCeutics Inc.. Completed at 42 sites in 2 countries. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-12.

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

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study summary

The purpose of this Phase III trial is to evaluate 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 450 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 who have self-identified symptom(s) of vaginal atrophy
  • For non-hysterectomized women, willing to have endometrial at baseline and end of study

Exclusion criteria

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 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
450 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

    Also known as: Prasterone, Dehydroepiandrosterone

  • DrugDHEA

    Vaginal suppository containing 0.5% (6.5 mg) DHEA

    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 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. 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.

    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 Vaginal Dryness

    The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of 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

Secondary outcomes

  1. Change From Baseline to Week 12 in Severity 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

  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 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.

    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 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.

    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 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.

    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 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.

    Time frame: Baseline and Week 12

07

Results

Posted Jun 12, 2017

Participant flow

A total of 897 subjects were screened at 42 medical/research sites located in the US (32 centers) and Canada (10 centers) and 450 subjects were randomized. The first subject first visit was on 21-JUN-2011 and the last subject last visit was on 12-APR-2012.

Participant flow — Overall Study
MilestonePlacebo0.25% DHEA0.50% DHEA
Started152148150
Safety population150143148
Itt population139134134
Completed130128125
Not completed222025
Withdrew: Adverse event343
Withdrew: Lost to follow-up113
Withdrew: Withdrawal by subject532
Withdrew: Physician decision101
Withdrew: Entry criteria not met/non-compliance121216

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 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
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
Baseline60.66 ± 3.4056.74 ± 3.6959.54 ± 3.41
Week 1262.22 ± 3.4939.23 ± 3.1533.02 ± 3.09
Change from Baseline to Week 121.56 ± 1.98-17.51 ± 2.74-26.52 ± 2.94
PrimaryChange 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.

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
Baseline0.97 ± 0.131.12 ± 0.130.93 ± 0.11
Week 121.80 ± 0.293.43 ± 0.343.58 ± 0.41
Change from Baseline to Week 120.83 ± 0.262.31 ± 0.322.66 ± 0.41
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 · pH units
Change From Baseline to Week 12 in Vaginal pH
pH unitsPlacebo0.25% DHEA0.50% DHEA
Baseline6.34 ± 0.056.27 ± 0.066.29 ± 0.06
Week 126.06 ± 0.085.69 ± 0.095.67 ± 0.08
Change from Baseline to Week 12-0.28 ± 0.06-0.58 ± 0.07-0.62 ± 0.07
PrimaryChange From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness

The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of 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 · Severity score
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
Severity scorePlacebo0.25% DHEA0.50% DHEA
Baseline2.38 ± 0.042.37 ± 0.042.35 ± 0.04
Week 121.27 ± 0.071.10 ± 0.071.13 ± 0.08
Change from Baseline to Week 12-1.12 ± 0.08-1.28 ± 0.08-1.22 ± 0.08
SecondaryChange From Baseline to Week 12 in Severity 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 · Severity score
Change From Baseline to Week 12 in Severity of Dyspareunia
Severity scorePlacebo0.25% DHEA0.50% DHEA
Baseline2.56 ± 0.052.58 ± 0.052.60 ± 0.05
Week 121.78 ± 0.111.48 ± 0.121.54 ± 0.10
Change from Baseline to Week 12-0.78 ± 0.10-1.10 ± 0.12-1.06 ± 0.10
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 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · Severity score
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Severity scorePlacebo0.25% DHEA0.50% DHEA
Baseline2.71 ± 0.052.55 ± 0.062.55 ± 0.06
Week 122.33 ± 0.062.07 ± 0.082.07 ± 0.06
Change from Baseline to Week 12-0.38 ± 0.05-0.48 ± 0.08-0.48 ± 0.07
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 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · Severity score
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Severity scorePlacebo0.25% DHEA0.50% DHEA
Baseline2.32 ± 0.072.19 ± 0.072.19 ± 0.08
Week 121.94 ± 0.071.74 ± 0.071.69 ± 0.07
Change from Baseline to Week 12-0.38 ± 0.06-0.46 ± 0.07-0.50 ± 0.08
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 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · Severity score
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Severity scorePlacebo0.25% DHEA0.50% DHEA
Baseline2.78 ± 0.062.66 ± 0.062.72 ± 0.06
Week 122.40 ± 0.072.25 ± 0.072.16 ± 0.06
Change from Baseline to Week 12-0.38 ± 0.06-0.40 ± 0.07-0.56 ± 0.07
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 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · Severity score
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Severity scorePlacebo0.25% DHEA0.50% DHEA
Baseline2.66 ± 0.052.60 ± 0.062.65 ± 0.06
Week 122.31 ± 0.072.16 ± 0.072.12 ± 0.06
Change from Baseline to Week 12-0.35 ± 0.06-0.45 ± 0.07-0.53 ± 0.07

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—5/150 (3.3%)19/150 (12.7%)
0.25% DHEA—1/143 (0.7%)17/143 (11.9%)
0.50% DHEA—1/148 (0.7%)23/148 (15.5%)
Most frequent serious events
Most frequent serious events
EventPlacebo0.25% DHEA0.50% DHEA
Movement disorderNervous system disorders0/1501/1430/148
CellulitisInfections and infestations0/1500/1431/148
Gastritis erosiveGastrointestinal disorders1/1500/1430/148
PancreatitisGastrointestinal disorders1/1500/1430/148
Small intestinal obstructionGastrointestinal disorders1/1500/1430/148
StressPsychiatric disorders1/1500/1430/148
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/1500/1430/148
Most frequent other events
Most frequent other events
EventPlacebo0.25% DHEA0.50% DHEA
Urinary tract infectionInfections and infestations9/15010/14314/148
NasopharyngitisInfections and infestations10/1507/1439/148

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)Placebo0.25% DHEA0.50% DHEATotal
Mean57.59 ± 6.4758.41 ± 6.0258.33 ± 6.1658.11 ± 6.22
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Placebo0.25% DHEA0.50% DHEATotal
Female150143148441
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo0.25% DHEA0.50% DHEATotal
White caucasian135132131398
Black or African American1291334
Asian1113
American Indian or Alaska Native1001
Other1135
08

Study locations

42 sites
  • EndoCeutics site # 39
    Montgomery, Alabama 36117, United States
  • EndoCeutics site # 14
    Tucson, Arizona 85712, United States
  • EndoCeutics site # 65
    Little Rock, Arkansas 72204, United States
  • EndoCeutics site # 21
    Sacramento, California 95821, United States
  • EndoCeutics site # 30
    San Diego, California 92108, United States
  • EndoCeutics site # 36
    Denver, Colorado 80218, United States
  • EndoCeutics site # 52
    Denver, Colorado 80220, United States
  • EndoCeutics site # 66
    Danbury, Connecticut 06810, United States
  • EndoCeutics site # 42
    Milford, Connecticut 06460, United States
  • EndoCeutics site # 57
    West Hartford, Connecticut 06117, United States
  • EndoCeutics site # 61
    Newark, Delaware 19718, United States
  • EndoCeutics site # 26
    Jacksonville, Florida 32207, United States
  • EndoCeutics site # 60
    Lake Worth, Florida 33461, United States
  • EndoCeutics site # 54
    North Miami, Florida 33161, United States
  • EndoCeutics site # 56
    Pinellas Park, Florida 33781, United States
  • EndoCeutics site # 23
    Sandy Springs, Georgia 30328, United States
  • EndoCeutics site # 10
    Meridian, Idaho 83642, United States
  • EndoCeutics site # 55
    Wichita, Kansas 67226, United States
  • EndoCeutics site # 27
    Baltimore, Maryland 21285-6815, United States
  • EndoCeutics site # 24
    Omaha, Nebraska 68131, United States
  • EndoCeutics site # 50
    Neptune City, New Jersey 07753, United States
  • EndoCeutics site # 33
    Beachwood, Ohio 44122, United States
  • EndoCeutics site # 05
    Cleveland, Ohio 44122, United States
  • EndoCeutics site # 47
    Cleveland, Ohio 44124, United States
  • EndoCeutics site # 15
    Columbus, Ohio 43213, United States
  • EndoCeutics site # 62
    Providence, Rhode Island 02930, United States
  • EndoCeutics site # 64
    Jackson, Tennessee 38305, United States
  • EndoCeutics site # 63
    Memphis, Tennessee 38120, United States
  • EndoCeutics site # 53
    San Antonio, Texas 78205, United States
  • EndoCeutics site # 51
    Sandy City, Utah 84070, United States
  • EndoCeutics site # 09
    West Jordan, Utah 84088, 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 # 59
    Toronto, Ontario M5B 1W8, 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

  • Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi E, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. Climacteric. 2015;18(4):590-607. doi: 10.3109/13697137.2014.992012. Epub 2015 Mar 3. PubMed 25511551 ↗
  • 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 ↗
10

Timeline

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

The record gives a start of Jun 2011, a primary completion of Apr 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2017, 5 years 2 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
May 20, 2011
First posted
May 24, 2011
Start
Jun 2011
Primary completionActual
Apr 2012
CompletionActual
May 2012
Results delay requested
May 1, 2013
Results first posted
Jun 12, 2017
Last update
Jun 12, 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 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01358760
Lead sponsor
EndoCeutics Inc.
Responsible party
Sponsor
First posted
May 24, 2011
Start date
Jun 2011
Primary completion
Apr 2012
Completion
May 2012
Results posted
Jun 12, 2017
Last update
Jun 12, 2017

Study contacts

David 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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