Topical Estriol for Vaginal Health
Completed · Phase 1 · Has a placebo group
Conditions studied: Vaginal Health
In brief
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.
Key facts
- Study ID
- NCT00908570
- Run by
- Gynuity Health Projects
- People needed
- 104
- Starts
- 2009-06-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2011-03-04
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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;
Where it is running
- Harbor-UCLA Medical Center — Los Angeles, California, United States
- University of Illinois at Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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