Topical Estriol for Vaginal Health

Sponsor

Gynuity Health Projects (Other)

Overall Status

Completed

CT.gov ID

NCT00908570

Collaborator

University of Illinois at Chicago (Other), University of California, Los Angeles (Other), Tulane University School of Medicine (Other), Magee-Women's Research Institute (Other), Oregon Health and Science University (Other)

104

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Health	Drug: estriol Drug: Placebo	Phase 1

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 the proposed study is to take the first steps in testing the effects of local estrogen treatment on vaginal health parameters in humans. We have chosen an estriol product because, in comparison with estrone (E1) and estradiol (E2), estriol (E3) is generally considered to be a weak estrogen. The duration of estriol's interaction with the estrogen receptor is quick and exhibits rapid metabolic clearance. We have chosen a topical route of administration because it appears to result in fewer systemic effects than oral administration, while allowing us to concentrate treatment locally in the areas we wish to affect.

Our primary goal is to test whether or not topically applied estrogen results in significant thickening and maturation of the vaginal epithelium. Our secondary goal is to measure the treatment's effects on other parameters of the vagina, such as Lactobacillus colonization and vaginal pH. If estrogen cream does indeed affect the vaginal environment in pre-menopausal women as it does in post-menopausal women, further study would be indicated to determine whether estrogen cream in the vagina decreases risk of infection in pre-menopausal women.

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Topical Estriol for Vaginal Health

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1Topical estriol cream	Drug: estriol 4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.
Placebo Comparator: 2Placebo cream	Drug: Placebo Placebo cream

Arm

Intervention/Treatment

Experimental: 1Topical estriol cream

Drug: estriol

4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.

Placebo Comparator: 2Placebo cream

Drug: Placebo

Placebo cream

Outcome Measures

Primary Outcome Measures

Change in thickness of the vaginal epithelium [Pre and post treatment luteal and follicular phases]

Secondary Outcome Measures

Other vaginal parameters including Lactobacillus colonization and vaginal pH [Pre and post treatment follicular and luteal phases]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.