A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy

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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