NCT00908570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

May 26, 2009

Last Update Submit

March 3, 2011

Conditions

Vaginal Health

Keywords

estrogenestriolcreamvaginainfection prevention

Outcome Measures

Primary Outcomes (1)

  • Change in thickness of the vaginal epithelium

    Pre and post treatment luteal and follicular phases

Secondary Outcomes (1)

  • Other vaginal parameters including Lactobacillus colonization and vaginal pH

    Pre and post treatment follicular and luteal phases

Study Arms (2)

1Topical estriol cream

EXPERIMENTAL
Drug: estriol

2Placebo cream

PLACEBO COMPARATOR
Drug: Placebo

Interventions

estriolDRUG

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

1Topical estriol cream
PlaceboDRUG

Placebo cream

2Placebo cream

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • 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);
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harbor-UCLA Medical Center

Los Angeles, California, 90502, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Estriol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Yael Swica, M.D., M.P.H.

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 4, 2011

Record last verified: 2011-03

Locations

US(2)