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

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

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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 |
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.

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

Principal Investigator: | David F Archer, MD | Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA |
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 |
Vulvar/Vaginal Atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA |
Prasterone Vaginorm Menopause Intrarosa |
Atrophy Pathological Conditions, Anatomical Dehydroepiandrosterone |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |