Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Atrophy

Treatments: Drug: WC3011 Estradiol Vaginal Cream; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01845649

PR-08112

Details and patient eligibility

About

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

Enrollment: 550 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
• Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
• Age ≥40 years; ≥35 with bilateral oophorectomy
• Vaginal pH >5.0
• Less than or equal to 5% superficial cells on vaginal wall cytologic smear
• Normal clinical breast exam or negative mammogram if ≥ 40 years of age
• Negative urine pregnancy test (non-hysterectomized and <12 months amenorrhea)

Exclusion criteria

• Enrollment in Sponsor's Study PR-04409 or PR-05812
• Participation in clinical trial or use of investigational drug within 30 days prior to screening
• Known hypersensitivity to estrogen and/or progestin therapy
• Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
• Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or >50% angiographic narrowing of coronary artery
• Thrombophlebitis or thromboembolic disorder or history of
• Insulin-dependent diabetes mellitus
• Increased frequency or severity of headaches while on hormone or estrogen therapy
• Currently taking St. John's Wort
• Drug/alcohol addiction within past 2 years
• Treatment with anticoagulants (heparin or warfarin)
• Smoking ≥15 cigarettes/day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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550 participants in 2 patient groups

Vehicle (3 Times/Week)

Active Comparator group

Description:

Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.

Treatment:

Drug: Vehicle

WC3011 Estradiol Vaginal Cream (3 Times/Week)

Experimental group

Description:

WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.

Treatment:

Drug: WC3011 Estradiol Vaginal Cream