Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symp… (NCT01376349) | Clinical Trial Compass
CompletedPhase 3
Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
United States464 participantsStarted 2011-07
Plain-language summary
RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors.
PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Age ≥ 18 years
✓. Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease). Note: Postmenopausal status will be determined by the following criteria:
✓. 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study
✓. menopausal status will be determined by an FSH and an estradiol value in the postmenopausal range (generally FSH \> 40IU/L and estradiol \< 10 pg/ml, depending on laboratory) if:
✓. Significant vaginal complaints. Note: Defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention.
✓. Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia. The protocol contains more information.
✓. Vaginal symptoms must have been present ≥ 2 months prior to randomization.
✓. Life expectancy \> 12 months.
Exclusion criteria
✕. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 12-week study.
✕. Current diagnosis of an active vaginal infection, if symptoms of vaginal infection, this must be ruled out (ie, foul discharge, fever).
What they're measuring
1
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks
✕. Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab is allowed.
✕. Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly) are allowed during sexual intercourse.
✕. Use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry.
✕. Current (≤ 4 weeks prior to randomization), or planned during the study period, use of any estrogen product or any kind of hormonal vaginal product including bioidentical hormones, estriol or any androgen product.
✕. Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie milk is acceptable).
✕. On a placebo controlled trial for endocrine therapy.