IntrarosaExamining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy

Inclusion Criteria:

1. Postmenopausal women aged 40 to 80 years.
2. Women who have self-identified at screening pain at sexual activity as moderate to severe and most bothersome symptom of vulvovaginal atrophy (Refer to Vaginal Atrophy Symptoms Questionnaire (VASQ-MBS)).
3. Women having ≤5% of superficial cells on vaginal smear at screening.
4. Women having a vaginal pH above 5 at screening.
5. Willing to participate in the study and sign an informed consent.

Exclusion Criteria:

1. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication.
2. Use of estrogen injectable drug therapy and/or progestin implant within 6 months prior to screening visit.
3. Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy within 8 weeks prior to screening visit.
4. Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to screening visit.
5. Previous treatment with androgens or anabolic steroids within 3 months prior to screening visit (see Appendix 15.1 - Concomitant medications).
6. Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance.
7. The administration of any investigational drug within 30 days of screening visit.
8. Clinically significant abnormal serum biochemistry, urinalysis or hematology (as per Investigator's assessment who should take into account the patient's pre-baseline conditions).
9. Uterine palpable fibroids.
10. Uterine prolapse (when the cervix reaches labia minora at gynecologic exam).
11. Subjects who suffer from vulvar lichen sclerosus or any vulvar dermatological disorder that affects the vulvar vestibule or vagina.
12. Chronic use of narcotics or alcoholism during the last 5 years.