Vaginal HealthPhase 1NCT00908570
Topical Estriol for Vaginal Health
A Phase 1 study testing estriol in people with Vaginal Health, run by Gynuity Health Projects at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Health
- What is being tested?
- estriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 28Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Harbor-UCLA Medical Center
Los Angeles, California, 90502
About this study
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.
Read the 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.
- Conditions
- Vaginal Health
- Being tested
- estriol, Placebo
- Keywords
- estrogen, estriol, cream, vagina, infection prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estriolDrug
4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.
PlaceboDrug
Placebo cream
| Study group | Role | What they receive |
|---|---|---|
| 1Topical estriol cream | Experimental | Not described Receives: Drug: estriol |
| 2Placebo cream | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thickness of the vaginal epithelium
Measured: Pre and post treatment luteal and follicular phases
Secondary outcomes (1)
Other vaginal parameters including Lactobacillus colonization and vaginal pH
Measured: Pre and post treatment follicular and luteal phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, University of California, Los Angeles, Tulane University School of Medicine, Magee-Women's Research Institute, Oregon Health and Science University
- Investigators
- Yael Swica, M.D., M.P.H., Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908570
- Sponsor's protocol ID
- 5.1
- Status last verified
- Mar 2011
- First submitted
- 26 May 2009
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Estriol for Vaginal Health
- ClinicalTrials.gov ID
- NCT00908570
- Acronym / sponsor ID
- 5.1
- Conditions
- Vaginal Health
- Keywords
- estrogen, estriol, cream, vagina, infection prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of California, Los Angeles, Tulane University School of Medicine, Magee-Women's Research Institute, Oregon Health and Science University
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Topical estriol cream | Experimental | Drug: estriol |
| 2Placebo cream | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estriol4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months. | Drug | 1Topical estriol cream |
| PlaceboPlacebo cream | Drug | 2Placebo cream |
Primary outcome
Change in thickness of the vaginal epithelium
Time frame: Pre and post treatment luteal and follicular phases
1 secondary outcome
Other vaginal parameters including Lactobacillus colonization and vaginal pH
Time frame: Pre and post treatment follicular and luteal phases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Swica, M.D., M.P.H. principal investigator
Gynuity Health Projects
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing estriol in people with Vaginal Health, run by Gynuity Health Projects at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in thickness of the vaginal epithelium (time frame: Pre and post treatment luteal and follicular phases). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2011; AzTrials last refreshed its copy on 6 Nov 2026.