| Eligibility |
Inclusion Criteria:
1. Subject is between 40 and 80 years of age inclusive;
2. Menopausal women (with or without hysterectomy) must also meet 1 of the following 3
conditions:
A Non-hysterectomy, menopause = 12 months; B. Menopause > 6 months and < 12 months or
premenopausal hysterectomy, follicle stimulating hormone (FSH) > 40 IU/L; C = 6 months
since baseline assessment (Day 1) with or without hysterectomy.
3. 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.
4. = 5% superficial cells by vaginal smear at screening and baseline (Day 1).
5. Vaginal pH > 5 at Screening and Baseline (Day 1).
6. 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.
7. 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).
8. 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).
9. Voluntarily participate in this clinical trial and sign the informed consent form
(ICF).
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Exclusion Criteria:
1. Patients with a history of malignant tumor.
2. Have active or history of thromboembolic disease (excluding thromboembolic events due
to accidents, surgery, immobilization).
3. Clinically significant endocrine metabolic disease (e.g., diabetes mellitus) not
controlled with medication.
4. Use of estrogen injections, estrogen implant sticks, progestogen injections,
progestogen implants, androgens, anabolic steroids within 6 months of the screening
visit.
5. 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.
6. Confirmed depression with poor control under standard treatment or history of
diagnosed psychiatric disorder.
7. 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.
8. 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.
9. Grade 2 and higher uterine prolapse (cervix reaching labia minora).
10. Transvaginal ultrasound revealed a uterine fibroid = 3 cm in diameter.
11. Endometrial thickness = 4 mm by transvaginal ultrasound, or other comprehensive
assessment by the investigator with the possibility of endometrial hyperplasia,
deterioration.
12. Current endometrial polyps.
13. Previous endometrial ablation.
14. Patients with vulvar lichen sclerosus.
15. Patients with unexplained vaginal bleeding.
16. Patients who are known to be allergic to the study drug or its ingredients.
17. Patients who have participated in other relevant clinical trials of the
investigational drug (prasterone vaginal suppositories).
18. History of past or present drug or alcohol abuse (14 units of alcohol per week: 1 unit
= 285 mL of beer, or 25 mL of spirits, or 100 mL of wine).
19. Subjects who are unable to perform the procedures required by the protocol, or any
other subjects who are not suitable for this clinical study judged by the
investigator.
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