CompletedPhase 3

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

United States1,050 participantsStarted 2022-11-15

Plain-language summary

Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.

Who can participate

Age range40 Years – 75 Years

SexFEMALE

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Inclusion criteria

✓. Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations.
✓. Females aged 40-75 years inclusive who are postmenopausal, with at least:
✓. 12 months of spontaneous amenorrhea (women \<55 year of age with history of hysterectomy without bilateral oophorectomy prior to natural menopause must have Serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL); or
✓. 6 months of spontaneous amenorrhea with FSH levels \>40mIU/mL; or
✓. At least 6 weeks postsurgical bilateral oophorectomy
✓. Have less than or equal to 5% superficial cells on vaginal cytological smear.
✓. Vaginal pH \> 5.0.
✓. 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).

Exclusion criteria

✕. Premenopasual, perimenopausal, pregnant or lactating patient or planning a pregnancy.
✕. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
✕. Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patients' safety.
✕. Significant history of cholestatic jaundice, hypertension, coronary heart disease or other serious heart problems, uncontrolled diabetes, hypercholesterolemia, hypercalcemia, hypoparathyroidism, hypertriglyceridemia, systemic lupus erythematosus, renal impairment, residual endometriosis posthysterectomy, asthma, epilepsy, migraine, porphyria, hepatic hemangiomas that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
✕. History of Protein C, Protein S, or antithrombin deficiency, or other thrombophilic disorder.
✕. Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis.
✕. Patients with active vaginal herpes simplex infection or have had an outbreak within 40 days before Screening
✕. History of sexual abuse that in the opinion of the investigator may interfere with the patient's assessment of vaginal pain with sexual activity.

What they're measuring

Responder

Timeframe: 15 days

Change in Most Bothersome Symptom

Timeframe: 15 days

Trial details

NCT IDNCT05617820

SponsorTeva Pharmaceuticals USA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-15

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