Study to Evaluate Safety & Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 35 - Any |
Updated: | 11/30/-0001 |
Start Date: | April 2013 |
End Date: | October 2013 |
Contact: | Susan Tully |
Email: | susan.tully@wcrx.com |
Phone: | 973-442-3200 |
A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
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 subject
self-assessment when compared to vehicle.
Inclusion Criteria:
- Sexually active with self-identified dyspareunia (pain with sexual activity), at
least moderate to severe & most bothersome symptom of VVA (vulvovaginal atrophy)
- Postmenopausal & 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
- Normal clinical breast exam or negative mammogram if ≥ 40 years of age
- Negative urine pregnancy test (non-hysterectomized & <12 months amenorrhea
Exclusion Criteria:
- Enrollment 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 &/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
We found this trial at
23
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials