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DHEA Against Vaginal Atrophy - Safety Study of 12 Months

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Drug: DHEA Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Study Start Date : December 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arms and Interventions
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Arm Intervention/treatment
Experimental: DHEA
0.5% DHEA (intravaginal)
 Drug: DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Other Name: Prasterone, Dehydroepiandrosterone, Vaginorm


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256671


Locations
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Sponsors and Collaborators
EndoCeutics Inc.
Investigators
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Principal Investigator: David F Archer, MD Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
More Information
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Publications of Results:

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Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT01256671    
Other Study ID Numbers: ERC-230
First Posted: December 8, 2010    Key Record Dates
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: September 2017
Keywords provided by EndoCeutics Inc.:
Vulvar/Vaginal Atrophy
Atrophic Vaginitis
Dehydroepiandrosterone
DHEA
 Prasterone
Vaginorm
Menopause
Intrarosa
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical
Dehydroepiandrosterone
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs