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Trial record 16 of 237 for:    PRASTERONE

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01256671
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 8, 2010
Results First Submitted Date  ICMJE March 16, 2017
Results First Posted Date  ICMJE October 18, 2017
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium [ Time Frame: Baseline and Week 52 (or discontinuation) ]
    The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
  • Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels [ Time Frame: Baseline and Week 52 ]
    The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2010)
Change from baseline over time of clinical safety data: adverse event (AE) reporting, vital signs, physical examination findings, gynecological examination findings, clinical laboratory tests, endometrial biopsy, mammography and Pap smear. [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). [ Time Frame: Baseline and Week 52 ]
    The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
  • Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). [ Time Frame: Baseline and Week 52 ]
    The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
  • Change From Baseline to Week 52 of Vaginal pH. [ Time Frame: Baseline and Week 52 ]
    A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
  • Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia [ Time Frame: Baseline and Week 52 ]
    The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
  • Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness [ Time Frame: Baseline and Week 52 ]
    The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
  • Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching [ Time Frame: Baseline and Week 52 ]
    The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2010)
  • Change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells). [ Time Frame: 52 weeks ]
  • Change from baseline over time of vaginal pH. [ Time Frame: 52 weeks ]
  • Change from baseline over time of self-assessment of symptoms of vulvar/vaginal atrophy. [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Official Title  ICMJE DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Brief Summary The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vaginal Atrophy
Intervention  ICMJE Drug: DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Other Name: Prasterone, Dehydroepiandrosterone, Vaginorm
Study Arms  ICMJE Experimental: DHEA
0.5% DHEA (intravaginal)
Intervention: Drug: DHEA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2013)
530
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2010)
450
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

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

Main Exclusion Criteria:

  • Undiagnosed abnormal genital bleeding.
  • Hypertension equal to or above 140/90 mm Hg.
  • The administration of any investigational drug within 30 days of screening visit.
  • Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01256671
Other Study ID Numbers  ICMJE ERC-230
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EndoCeutics Inc.
Study Sponsor  ICMJE EndoCeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David F Archer, MD Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
PRS Account EndoCeutics Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP