Topical Estriol for Vaginal Health

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Magee-Women's Research Institute; Oregon Health and Science University; Tulane University School of Medicine; University of California, Los Angeles; University of Illinois at Chicago

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.