Atrophic VaginitisPhase 3NCT00816556

A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

A Phase 3 study testing Estriol, Estradiol valerate and Vanicream Lite in people with Atrophic Vaginitis, run by Maire Mac Bride at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse. Other symptoms can include urinary frequency and urinary urgency. Read more about this study

Who is it for?: Ages 40 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Atrophic Vaginitis
What is being tested?: Estriol, Estradiol valerate and Vanicream Lite
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteUnited States
Study dates: Oct 2008to Dec 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Postmenopausal women (no menses for the previous 12 months)
Dryness, itching or burning in and around the vagina
Discontinued hormone replacement therapy (either local or systemic) at least 3 months

Who cannot join

Known, suspected, or history of cancer of the breast.
Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
Known hypersensitivity to any component of the medications or base creams.
Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).
Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L.

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Undiagnosed abnormal genital bleeding.
Known chronic lichen sclerosis.
Known, untreated vaginal infection.
Not had a normal screening mammogram within the last 15 months.
Hysterectomy without oophorectomy unless 60 years or older.
Women taking aromatase inhibitors or tamoxifen.
Hgb <12.0 or >15.5 g/dL
Urinalysis showing a urinary tract infection (UTI).

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at the lowest dose for the shortest time. We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream.

We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a placebo cream. Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and is only available at compounding pharmacies. We want to see if either of these estrogens is effective at one tenth the usual dose. We also want to see if these creams are effective when massaged onto the outer part of the vagina, rather than the usual method of treatment, which is inserting them into the vagina.

Read the detailed description

This trial will measure the effects of very low doses of estradiol or estriol cream applied to the vaginal introitus for the treatment of atrophic vaginitis, a common condition affecting up to 40% of postmenopausal women. We will conduct a randomized controlled trial with three arms-estradiol, estriol and placebo. The intervention will last for 12 weeks. The outcomes we will be most interested in are the efficacy of the treatments for symptoms of atrophic vaginitis compared to placebo and whether there is any measurable systemic absorption from the locally applied estrogen creams. These outcomes will be measured, primarily, by the use of patient questionnaires and secondarily, clinical examination scores. Safety will be evaluated with serum estrogen concentrations. All measures will be collected at baseline and at the termination of the study. Hormone concentrations will be collected, additionally, at week 2. This trial will answer important questions regarding the impact of very low doses of locally applied estrogens and symptoms of atrophic vaginitis. It will provide information on effect size and validity of outcome measures. It will also give information about whether low doses of estrogen creams, locally applied to the vaginal introitus, result in systemic absorption

Conditions: Atrophic Vaginitis
Being tested: Estriol, Estradiol valerate, Vanicream Lite
Medical subject headings: Atrophic Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EstriolDrug
Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for 2 weeks and then twice weekly for 10 weeks.
Estradiol valerateDrug
Also called Delestrogen
Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Vanicream LiteDrug
Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Study groups in NCT00816556
Study group	Role	What they receive
Estriol	Active comparator	Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks Receives: Drug: Estriol
Estradiol	Active comparator	Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks Receives: Drug: Estradiol valerate
Vanicream Lite	Placebo comparator	Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks Receives: Drug: Vanicream Lite

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12
The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.
Measured: baseline, 12 weeks

Secondary outcomes (2)

Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks
Measured: baseline, 2 weeks, 12 weeks
Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks
Measured: baseline, 2 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Dec 2011

First posted1 Jan 2009 (estimated)
Study startOct 2008
Primary completionSep 2011
Study completionDec 2011

Why it stopped: Funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrophic VaginitisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00816556
Sponsor's protocol ID: 07-008730
Other IDs: UL1TR000135
Status last verified: Oct 2017
First submitted: 30 Dec 2008
Last updated: 13 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Active, not recruiting
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms
Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
Postmenopausal Atrophic Vaginitis, Genitourinary Syndrome of Menopause

All Atrophic Vaginitis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
ClinicalTrials.gov ID: NCT00816556
Acronym / sponsor ID: 07-008730
Conditions: Atrophic Vaginitis
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding
Enrolment: 63 participants (actual)
Lead sponsor: Maire Mac BrideUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: Oct 2008
Primary completion: Sep 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 1 Jan 2009 (estimated)
Results: Posted 28 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Estriol	Active comparator	Drug: EstriolEstriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Estradiol	Active comparator	Drug: Estradiol valerateEstradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Vanicream Lite	Placebo comparator	Drug: Vanicream LiteVanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Who may qualify

Ages: 40 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Postmenopausal women (no menses for the previous 12 months)
Dryness, itching or burning in and around the vagina
Discontinued hormone replacement therapy (either local or systemic) at least 3 months

Key exclusion criteria (14 listed)

Known, suspected, or history of cancer of the breast.
Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
Known hypersensitivity to any component of the medications or base creams.
Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).

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
EstriolEstriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for 2 weeks and then twice weekly for 10 weeks.	Drug	Estriol
Estradiol valerateAlso: DelestrogenEstradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Drug	Estradiol
Vanicream LiteVanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Drug	Vanicream Lite

Primary outcome

Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12
Time frame: baseline, 12 weeks
The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.

2 secondary outcomes

Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks
Time frame: baseline, 2 weeks, 12 weeks
Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks
Time frame: baseline, 2 weeks, 12 weeks

Results and safety

Results posted to the registry on 28 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estriol	20	18
Estradiol	21	19
Placebo	22	19

Primary outcome: Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12

Time frame: baseline, 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Estriol n = 18	Estradiol n = 19	Placebo n = 19
Dryness Severity	3.2 (2.3)	2.0 (3.3)	2.7 (2.7)
Dryness Bothersomeness	2.3 (2.8)	2.1 (2.7)	3.6 (3.1)
Itching Severity	1.4 (1.6)	2.6 (2.9)	1.9 (2.8)
Itching Bothersomeness	1.3 (1.6)	2.6 (3.0)	1.7 (2.5)
Burning Severity	2.1 (2.6)	1.5 (2.5)	1.0 (2.9)
Burning Bothersomeness	1.9 (2.7)	1.5 (2.6)	1.1 (3.1)

Estriol vs Estradiol vs Placebo: p = 0.42, ANOVA
Estriol vs Estradiol vs Placebo: p = 0.22, ANOVA
Estriol vs Estradiol vs Placebo: p = 0.37, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estriol	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
Estradiol	0 of 19 (0%)	0 of 19 (0%)	Not reported
Placebo	0 of 19 (0%)	1 of 19 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrophic Vaginitis

Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Active, not recruiting
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms
Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
Postmenopausal Atrophic Vaginitis, Genitourinary Syndrome of Menopause

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.

Maire B Mac Bride, MB BCh principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estriol, Estradiol valerate and Vanicream Lite in people with Atrophic Vaginitis, run by Maire Mac Bride at 1 site 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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00816556.

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 13 Nov 2017.