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

Use our guide to learn which trials are right for you!

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
Greensboro, North Carolina 27408
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Bluffton, South Carolina 29910
?
mi
from
Bluffton, SC
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Chaska, MN
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Granger, Indiana 46530
?
mi
from
Granger, IN
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jenkintown, Pennsylvania 19046
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Kentucky 40509
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Marrero, LA
Click here to add this to my saved trials
Moorestown, New Jersey 08057
?
mi
from
Moorestown, NJ
Click here to add this to my saved trials
New London, Connecticut 06320
?
mi
from
New London, CT
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Salt Lake City, Utah 84121
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Seattle, Washington 98105
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Washington, District of Columbia 20036
?
mi
from
Washington,
Click here to add this to my saved trials