A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy (NCT04982692) | Clinical Trial Compass
CompletedPhase 3
A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy
China417 participantsStarted 2021-09-13
Plain-language summary
This study is a phase III which includes two treatment phases. The phase 1 study is a multi-center, randomized, double-blind, placebo- controlled, parallel group that provide primary efficacy and safety data.
The Phase 2 study is a single-arm, open-label conducted in a subset of subjects who completed the phase 1 study to provid additional long-term safety and efficacy.
Who can participate
Age range40 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. Subject is between 40 and 80 years of age inclusive;
✓. Menopausal women (with or without hysterectomy) must also meet 1 of the following 3 conditions:
✓. At screening and baseline (Day 1), the subject presented with moderate-severe dyspareunia (dyspareunia) as measured by the Vaginal Atrophy Symptom Questionnaire (VASQ) and self-rated as the most bothersome symptom.
✓. ≤ 5% superficial cells by vaginal smear at screening and baseline (Day 1).
✓. Vaginal pH \> 5 at Screening and Baseline (Day 1).
✓. Women (with or without a partner) who currently have sex or other sexual activity (masturbation, etc.) at least once a month, or who have sex or other sexual activity at least once a month in the past, with reduced sexual activity due to excessive pain or vaginal dryness.
✓. Normal physical examination of the breast and normal mammographic findings (BI-RADS grade 1 or 2) within 9 months prior to the baseline visit (Day 1).
✓. Normal cervical smear results (including inflammatory changes), regardless of hysterectomy (no abnormal cervical smear in the past 2 years if ASCUS is present, and human papillomavirus (HPV) test negative can be used) within 12 months before the baseline visit (Day 1).
Exclusion criteria
✕. Patients with a history of malignant tumor.
✕. Have active or history of thromboembolic disease (excluding thromboembolic events due to accidents, surgery, immobilization).
What they're measuring
1
The change in the dyspareunia (dyspareunia) severity score at Day 85.
Timeframe: week 12
2
The change in the vaginal pH at Day 85.
Timeframe: week 12
3
The change in the proportion of parabasal cells at Day 85.
Timeframe: week 12
4
The change in the proportion of superficial cells at Day 85.
✕. Clinically significant endocrine metabolic disease (e.g., diabetes mellitus) not controlled with medication.
✕. Use of estrogen injections, estrogen implant sticks, progestogen injections, progestogen implants, androgens, anabolic steroids within 6 months of the screening visit.
✕. Use oral estrogen, oral progesterone, prasterone (DHEA) or intrauterine progesterone treatment, intravaginal hormonal drugs (ring, cream, gel or tablet), estrogen alone or estrogen/pregnancy within 8 weeks before the screening visit, hormone transdermal drug users.
✕. Confirmed depression with poor control under standard treatment or history of diagnosed psychiatric disorder.
✕. Those who have participated in or plan to participate in other drug or device clinical trials during the study period within 1 month prior to the screening visit.
✕. Laboratory findings suggestive of glutamic-pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) ≥ 2 times the upper limit of normal, or creatinine ≥ 1.5 times the upper limit of normal.