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Completed

NCT Number: NCT01256671

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

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.

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Key information

Conditions

Vaginal Atrophy Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

EndoCeutics site # 13, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DHEA

Drug

Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

Other names: Prasterone, Dehydroepiandrosterone, Vaginorm

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

EndoCeutics Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2010
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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