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Completed
NCT05617820
Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
Conditions: Dyspareunia
Sex: Female
Ages: 40 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 1050
Sponsor: Teva Pharmaceuticals USA
Location: Site 10112 Birmingham Alabama
Summary
Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.
Eligibility Criteria
Inclusion Criteria:
1. Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations.
2. Females aged 40-75 years inclusive who are postmenopausal, with at least:
1. 12 months of spontaneous amenorrhea (women \ 40 mIU/mL); or
2. 6 months of spontaneous amenorrhea with FSH levels \>40mIU/mL; or
3. At least 6 weeks postsurgical bilateral oophorectomy
3. Have less than or equal to 5% superficial cells on vaginal cytological smear.
4. Vaginal pH \> 5.0.
5. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom (dyspareunia) of VVA by the patient at screening visit. (i.e., a VVA Symptom Self-Assessment Questionnaire score of 2 or 3) (Appendix B).
6. Women should be sexually active (for example, have sexual activity with vaginal penetration within approximately one month of screening visit).
7. Women should anticipate having sexual activity (with vaginal penetration) during the conduct of the study, and agree to at least one episode of sexual intercourse within study days 10-13.
8. Baseline systolic blood pressure should be no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg.
9. Normal mammogram completed within 9 months before randomization and a normal clinical breast examination prior to randomization in the study.
10. Patients who have underwent complete Hysterectomy, or in the case of patients with an intact uterus (including patients who underwent a partial hysterectomy) the later must have:
1. A documented papanicolaou (PAP) smear conducted within 12 months before randomization with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
2. Documented vaginal ultrasonography results within 3 months before randomization to confirm an inactive endometrial lining, defined as endometrial thickness \ 350 mg/dL.
24. History of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
25. Any known or suspected allergies that in the Investigator's opinion would compromise the safety of the patient.
26. Patients who have used vaginal hormonal products (i.e. rings, creams, gels) within the 4 weeks before Screening.
27. Patients who have used transdermal estrogen and/or progestin therapy within the 4 weeks before Screening.
28. Patients who have used oral estrogen, progestin, androgen or selective estrogen receptor modular (SERM) containing drug products within 8 weeks before Screening visit.
29. Intrauterine progestin therapy within 8 weeks before Screening.
30. Use of an intrauterine device within 12 weeks before screening visit.
31. Patients who have used estrogen pellet therapy or progestin implants/ injectable drug therapy within the 6 months before Screening.
32. Patients who have engaged in sexual intercourse or used vaginal douching within 24 hours of the screening visit.
33. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
34. Patients who are unable or unwilling to give informed consent.
35. Current history of heavy smoking (more than 15 cigarettes per day) or use of e-cigarettes.
36. Current use of marijuana.
37. Recent history of known alcohol or drug abuse, within one year start of the study.
38. Employees of the Investigator or research center or their immediate family members.
39. Receipt of any drug as part of a research study within 60 days before Screening.
40. Previous participation in this study.
Source: ClinicalTrials.gov (NCT05617820). StuddyBuddy aggregates publicly available trial information.