Status:
UNKNOWN
Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
Lead Sponsor:
Center for Vulvovaginal Disorders
Collaborating Sponsors:
EndoCeutics Inc.
Conditions:
Menopause
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
40-80 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Tissues in the genitourinary system are both androgen- and estrogen-dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor are androgen-responsive. ...
Eligibility Criteria
Inclusion
- Postmenopausal women aged 40 to 80 years.
- 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)).
- Women having ≤5% of superficial cells on vaginal smear at screening.
- Women having a vaginal pH above 5 at screening.
- Willing to participate in the study and sign an informed consent.
Exclusion
- Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication.
- Use of estrogen injectable drug therapy and/or progestin implant within 6 months prior to screening visit.
- Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy within 8 weeks prior to screening visit.
- Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to screening visit.
- Previous treatment with androgens or anabolic steroids within 3 months prior to screening visit (see Appendix 15.1 - Concomitant medications).
- Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance.
- The administration of any investigational drug within 30 days of screening visit.
- Clinically significant abnormal serum biochemistry, urinalysis or hematology (as per Investigator's assessment who should take into account the patient's pre-baseline conditions).
- Uterine palpable fibroids.
- Uterine prolapse (when the cervix reaches labia minora at gynecologic exam).
- Subjects who suffer from vulvar lichen sclerosus or any vulvar dermatological disorder that affects the vulvar vestibule or vagina.
- Chronic use of narcotics or alcoholism during the last 5 years.
Key Trial Info
Start Date :
March 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03782480
Start Date
March 2 2019
End Date
January 2 2021
Last Update
January 31 2019
Active Locations (2)
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1
The Centers for Vulvovaginal Disorders
Washington D.C., District of Columbia, United States, 20037
2
The Centers for Vulvovaginal Disorders
New York, New York, United States, 10036