Status:
COMPLETED
Topical Estriol for Vaginal Health
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
University of Illinois at Chicago
University of California, Los Angeles
Conditions:
Vaginal Health
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase I study is to investigate and document the effects of local treatment with a topical estriol cream on the vaginal environment of pre-menopausal women.
Detailed Description
There is evidence from human studies that estrogen can give rise to health-promoting changes in the vaginal environment in addition to affecting the thickness of the vaginal epithelium. The purpose of...
Eligibility Criteria
Inclusion
- In generally good health
- Between the ages of 18 and 40
- Report regular, consistent menstrual cycles with duration between 25 and 35 days' duration
- Agree not to initiate hormonal contraception or other systemic or vaginal hormonal treatments during the course of the study
- Agree to refrain from vaginal douching and use of spermicides, spermicide-treated condoms, diaphragms, cervical caps, vaginal hygiene treatments and other vaginal products during the course of the study except as explicitly allowed under study protocol.
- Not attempting to get pregnant (and, if sexually active, using an allowed effective contraceptive - i.e., sterilization or male condoms)
Exclusion
- Has been informed by a health practitioner that she should avoid estrogen treatments
- Does not meet one or more of the above inclusion criteria
- Is currently pregnant
- Is currently lactating
- Has IUD in place
- Has diabetes that is controlled with medication
- Has menstrual bleeding that usually exceeds 7 days' duration
- Has used hormonal contraception or other systemic or vaginal hormonal treatment during the past three months
- Has received systemic antibiotic treatment since the start of bleeding in her current menstrual period
- Has known history of diagnosis of HIV infection
- Screens positive for gonorrhea, Chlamydia, or trichomonas
- Has evidence of high-grade dysplasia or cervical cancer on visual examination or Pap smear
- Has active genital Herpes lesions
- Has any of the following:
- Known, past or suspected breast cancer;
- Known or suspected estrogen-dependent malignant or pre-malignant tumours (e.g endometrial cancer);
- History of endometrial hyperplasia;
- Undiagnosed or abnormal genital bleeding;
- Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);
- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
- Acute liver disease, or a history of liver disease where liver function tests have failed to return to normal;
- Liver disorders such as adenomas;
- Symptomatic gallstones or gallbladder disease (cholecystitis);
- Hypertriglyceridemia;
- Vascular disease associated with lupus erythematosus;
- Known hypersensitivity to estriol (estrogen E3) or the inactive substances in the study product;
- Porphyria
- Presents any other history or condition that provider, in his or her best discretion, feels should rule out study participation.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00908570
Start Date
June 1 2009
End Date
March 1 2011
Last Update
March 4 2011
Active Locations (2)
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1
Harbor-UCLA Medical Center
Los Angeles, California, United States, 90502
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612