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

• Status: Unknown status
• Trial end date: 2021-01-02
• Target enrollment: 0
• Participant gender: Female

Summary

Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse.

Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse.

Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Vulvovaginal Disorders
• Collaborator: EndoCeutics Inc.
• Treatments: Dehydroepiandrosterone

Criteria

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.