A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Dyspareunia; Menopause; Vulvovaginal Atrophy

Treatments: Drug: Placebo; Drug: Estradiol Vaginal Capsule (EVC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02670785

EVC-MD-01

Details and patient eligibility

About

This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.

Enrollment: 203 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of vulvovaginal atrophy due to post menopause
• Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
• Moderate to severe vaginal dryness
• Normal breast exam; if > 40 years
• Vaginal pH > 5.0
• < 5% superficial cells on vaginal wall cytology smear

Exclusion criteria

• Known hypersensitivity to estrogen and/or progestin therapy
• Known or suspected premalignant or malignant disease
• Undiagnosed abnormal genital bleeding
• A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
• Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
• Increased frequency/severity headaches with estrogen therapy
• Smokes ≥ 15 cigarettes/day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

203 participants in 4 patient groups, including a placebo group

Estradiol Vaginal Capsule 0.003 mg

Experimental group

Description:

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Treatment:

Drug: Estradiol Vaginal Capsule (EVC)

Estradiol Vaginal Capsule 0.01 mg

Experimental group

Description:

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Treatment:

Drug: Estradiol Vaginal Capsule (EVC)

Estradiol Vaginal Capsule 0.02 mg

Experimental group

Description:

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Treatment:

Drug: Estradiol Vaginal Capsule (EVC)

Placebo

Placebo Comparator group

Description:

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Treatment:

Drug: Placebo