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.
The phase 1 study which includes the screening phase (up to 3 weeks) and treatment phase (12 weeks). After signing the informed consent, the inclusion and exclusion criteria will be confirmed preliminarily at screening visit and reconfirmed at Day 1 (baseline). At least 418 eligible subjects will be randomized in a 1:1 ratio to receive 6.5mg of intravaginal prasterone or placebo once-daily for 12 weeks. The phase 2 study which includes the treatment phase (26 weeks). A total of 100 subjects who have completed Phase 1, not occur adverse event(AE) grade ≥3 or serious adverse event (SAE), or recover all AE grades ≤1, and voluntary to participate in Phase 2 study. After signing the ICF, the subject will receive 6.5mg of intravaginal for 26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
417
6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.
Placebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, China
The change in the dyspareunia (dyspareunia) severity score at Day 85.
Compared with Day 1, the changes in the dyspareunia (dyspareunia) severity score (by VASQ) at Day 85 (12 weeks) in the two groups of subjects.
Time frame: week 12
The change in the vaginal pH at Day 85.
Compared with Day 1, the changes in the vaginal pH changes at Day 85 (12 weeks) in the two groups of subjects.
Time frame: week 12
The change in the proportion of parabasal cells at Day 85.
Compared with Day 1, the changes in the proportion of parabasal cells at Day 85 (12 weeks) in the two groups of subjects.
Time frame: week 12
The change in the proportion of superficial cells at Day 85.
Compared with Day 1, the changes in the proportion of superficial cells at Day 85 (12 weeks) in the two groups of subjects.
Time frame: week 12
Change in vaginal dryness and vaginal irritation/itching severity score at day 85 (12 weeks).
Compared with the baseline period, at day 85 (12 weeks) in both groups: change in vaginal dryness and vaginal irritation/itching severity score by VASQ.
Time frame: week 12
Change in Female Sexual Function Index at Day 85 (12 weeks).
Compared with the baseline period, the two groups at Day 85 (12 weeks): change in Female Sexual Function Index (FSFI questionnaire).
Time frame: week 12
Effects on DHEA in blood
To test the concentrations of DHEA in blood.
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Time frame: week 12
Changes in the gynecological vaginal examination.
The changes of total severity score in the vaginal discharge, vaginal epithelial integrity, vaginal epithelial surface thickness, and vaginal color by gynecological vaginal examination.
Time frame: week 12
Adverse event.
The proportion of adverse events.
Time frame: week 6,week 12