Atrophic VaginitisPhase 3NCT02195986

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

A Phase 3 study testing Estradiol Vaginal Cream, 0.01% and Estrace® 0.01% cream in people with Atrophic Vaginitis, run by Mylan Pharmaceuticals Inc at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment. Read more about this study

Who is it for?: Ages 40 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Atrophic Vaginitis
What is being tested?: Estradiol Vaginal Cream, 0.01% and Estrace® 0.01% cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 366 participants
Where: 21 sitesUnited States
Study dates: Jun 2014to Dec 2014
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 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Capable of providing informed consent.
Age: 40-70 years old.
Sex: Female
Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Weight: At least 48 kg with all subjects having a Body Mass Index less than or equal to 38 kg/m2 but greater than or equal to 19 kg/m2.
Baseline evaluation requirements:

Show all 30Show fewer

≤5% superficial cells on vaginal smear cytology
Vaginal pH > 5.0
At least one patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the subject:
Vaginal dryness
Vaginal and/or vulvar irritation/itching
Dysuria
Vaginal pain associated with sexual activity
Vaginal bleeding associated with sexual activity (absence vs. presence)
All subjects should be judged to be eligible for participation in this study by the principal or sub-investigator physician during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include:
a normal or non-clinically significant physical examination, including vital signs
a normal or non-clinically significant pelvic examination that was consistent with hypoestrogenemia
a normal or non-clinically significant breast exam and mammogram
a normal or non-clinically significant ASCUS Papanicolaou ("Pap") smear that is negative for HPV for subjects with an intact uterus and cervix
within normal limits or non-clinically significant laboratory evaluation results (unless otherwise noted in the exclusion criteria) for the following tests:
Serum Chemistry
Hematology
Coagulogram
Urinalysis
normal or non-clinically significant 12- Lead ECG.
negative urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine with the following exceptions: positive tests for amphetamines, barbiturates, benzodiazepines, or opiates may be allowed provided the subject has a valid prescription and is on a stable regimen that complies with Exclusion Criteria, Section 6.3.2.
negative urine cotinine test.
For women with an intact uterus, an endometrial thickness < 5 mm as determined by vaginal ultrasonography.
If warranted, other tests or examinations may be performed at the discretion of the Principal Investigator or responsible physician.
Ability to use applicator properly.

Who cannot join

Institutionalized subjects will not be used.
Any contraindication to estrogen therapy.
Social Habits:
Use of any tobacco-containing products within 1 year of the start of the study.
Regular intake of more than 7 units of alcohol per week.
Beginning any new regimens of vitamins or herbal products within 7 days prior to the initial dose of the study medication.

Show all 45Show fewer

Any recent, significant change in dietary or exercise habits.
History of drug and/or alcohol abuse within one year of start of study.
Medications:
Use of any new prescription or over-the-counter (OTC) medication regimens within fourteen (14) days prior to the initial dose of study medication (any necessary medication, unless otherwise noted in the exclusion criteria, for which dosing has been stabilized for a period of at least 14 days prior to initial dosing of study drug and is expected to remain stable for the entire study period is allowed, with the exception of acetaminophen, which may be administered as needed to treat minor adverse events).
Use of hormonal replacement therapies for the following time periods:
within 2 weeks of baseline assessment for vaginal therapy (rings, creams, gels)
within 4 weeks of baseline assessment for transdermal estrogen alone or estrogen/progestin therapy
within 8 weeks of baseline assessment for oral estrogen and/or progestin therapy or intrauterine progestin therapy
within 3 months of baseline assessments for progestin implants or estrogen alone injectable therapy
within 6 months of baseline assessments for estrogen pellet or progestin injectable therapy
A depot injection or implant of any drug within 3 months prior to administration of study medication.
Currently taking medication indicated for anticoagulation as a result of an excluded condition listed in #5 below. This includes but is not limited to warfarin, heparin, NSAIDs, clopidogrel, dabigatran, etc.
Diseases:
History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, urinary, musculoskeletal disease or malignancies unless under medical control and/or deemed not clinically significant by the Principal Investigator or Medical Sub-investigator.
Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or > 50% angiographic narrowing of coronary artery, thrombosis of deep veins and arteries, thromboembolic disorders, pulmonary embolism) or history of these conditions.
Coronary artery or cerebrovascular disease.
Current clinically significant liver or kidney dysfunction/disorders.
Current clinically significant gallbladder dysfunction/disorders.
Abnormal or clinically significant breast examination. Acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy.
First degree family history of breast cancer.
Current non diet controlled diabetes mellitus or other clinically significant endocrinological disease.
Estrogen-dependent neoplasia
Postmenopausal uterine bleeding
Endometrial hyperplasia
Uncontrolled hypothyroidism
Urinalysis showing an ongoing clinically significant urinary tract infection that requires treatment.
Current clinically significant vaginal infection that requires treatment.
Known chronic lichen sclerosis
Acute illness at the time of either the pre-study medical evaluation or dosing.
History of allergy or hypersensitivity to estradiol, other related products, or any inactive ingredients.
Undiagnosed vaginal bleeding or history of significant risk factors for endometrial cancer.
Increased frequency or severity of headaches while on previous hormone or estrogen therapy.
History of psychiatric disorders occurring within the last 6 months that require hospitalization or medication.
Current hypercalcemia, hypocalcemia, and/or hypertriglyceridemia.
Clinically significant eye/visual abnormalities such as retinal vascular thrombosis, partial or complete loss of vision, proptosis, diplopia, papilledema, retinal vascular lesions.
Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Sitting blood pressure higher than 150/90 mmHg at screening.
Baseline serum estradiol levels >30 pg/mL at screening.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Georgia Center for Women
Atlanta, Georgia, 30312
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
Sunrise Medical Research
Coral Springs, Florida, 33065
Downtown Women's Health Care
Denver, Colorado, 80209
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Health Awareness, Inc.
Jupiter, Florida, 33458
Meridien Research
Lakeland, Florida, 33805
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08690
OB-GYN Associates of Mid Florida
Leesburg, Florida, 34748
Axis Clinical Trials
Los Angeles, California, 90036
SouthCoast Research Center
Miami, Florida, 33136
Veritas Research, Corp.
Miami Lakes, Florida, 33014
Women's Health Research Center/The Center for Women's Health & Wellness, LLC
Plainsboro, New Jersey, 08536
Northern CA Research
Sacramento, California, 95821
MCCR
San Diego, California, 92108
Women's Health Care Research Corp.
San Diego, California, 92123
Physician Care Clinical Research LLC
Sarasota, Florida, 34239
Meridien Research
St. Petersburg, Florida, 33709
Sunrise Medical Research
Tamarac, Florida, 33351
ARA-Arizona Research Associates
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis

Conditions: Atrophic Vaginitis
Being tested: Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream, Placebo Vaginal Cream
Keywords: vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain and bleeding associated with sexual activity, vaginal atrophy
Medical subject headings: Atrophic Vaginitis, Pruritus, Dysuria

What participants receive

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

Estradiol Vaginal Cream, 0.01%Drug
Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)
Estrace® 0.01% creamDrug
Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days)
Placebo Vaginal CreamDrug
Placebo Vaginal Cream ( 1 x 2 g for 7 days)

Study groups in NCT02195986
Study group	Role	What they receive
Estradiol Vaginal Cream	Experimental	Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Receives: Drug: Estradiol Vaginal Cream, 0.01%
Estrace® 0.01% cream	Active comparator	Estrace® 0.01% vaginal cream, administered once daily for 7 days. Receives: Drug: Estrace® 0.01% cream
Placebo Vaginal Cream	Placebo comparator	Placebo Vaginal Cream, administered once daily for 7 days. Receives: Drug: Placebo Vaginal Cream

What is being measured

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

Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8.
A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.
Measured: Study Day 8
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8.
A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.
Measured: Study Day 8

Secondary outcomes (2)

Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence
Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.
Measured: Day 8
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo
Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.
Measured: Day 8

Timeline

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

Jun 2014Dec 2014

First posted21 Jul 2014 (estimated)
Study startJun 2014
Primary completionDec 2014
Study completionDec 2014

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: 366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02195986
Sponsor's protocol ID: EVCR-11196
Status last verified: Mar 2022
First submitted: 16 Jul 2014
Last updated: 9 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: N/A - Phase I study

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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
ClinicalTrials.gov ID: NCT02195986
Acronym / sponsor ID: EVCR-11196
Conditions: Atrophic Vaginitis
Keywords: vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain and bleeding associated with sexual activity, vaginal atrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 366 participants (actual)
Lead sponsor: Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 21 Jul 2014 (estimated)
Results: Posted 6 Sep 2017

Clinical summary

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

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
Estradiol Vaginal Cream	Experimental	Drug: Estradiol Vaginal Cream, 0.01%Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.
Estrace® 0.01% cream	Active comparator	Drug: Estrace® 0.01% creamEstrace® 0.01% vaginal cream, administered once daily for 7 days.
Placebo Vaginal Cream	Placebo comparator	Drug: Placebo Vaginal CreamPlacebo Vaginal Cream, administered once daily for 7 days.

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (30 listed)

Capable of providing informed consent.
Age: 40-70 years old.
Sex: Female
Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Weight: At least 48 kg with all subjects having a Body Mass Index less than or equal to 38 kg/m2 but greater than or equal to 19 kg/m2.

Key exclusion criteria (45 listed)

Institutionalized subjects will not be used.
Any contraindication to estrogen therapy.
Social Habits:
Medications:
Diseases:

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
Estradiol Vaginal Cream, 0.01%Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)	Drug	Estradiol Vaginal Cream
Estrace® 0.01% creamEstrace® 0.01% vaginal cream ( 1 x 2g for 7 days)	Drug	Estrace® 0.01% cream
Placebo Vaginal CreamPlacebo Vaginal Cream ( 1 x 2 g for 7 days)	Drug	Placebo Vaginal Cream

Primary outcome

Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence
Time frame: Study Day 8
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo
Time frame: Study Day 8
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.

2 secondary outcomes

Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence
Time frame: Day 8
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo
Time frame: Day 8

Results and safety

Results posted to the registry on 6 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estradiol Vaginal Cream	146	143
Estrace® 0.01% Cream	147	142
Placebo Vaginal Cream	73	71

Primary outcome: Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence

Time frame: Study Day 8. Count of participants. Unit: Participants

Measure	Estradiol Vaginal Cream n = 111	Estrace® 0.01% Cream n = 117
Value	42	45

Estradiol Vaginal Cream vs Estrace® 0.01% Cream: Difference: -0.0062 (90% CI -0.1209 to 0.1084)

Population analysed: The Per Protocol population was used for the primary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed primary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation

Primary outcome: Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo

Time frame: Study Day 8. Count of participants. Unit: Participants

Measure	Estradiol Vaginal Cream n = 125	Estrace® 0.01% Cream n = 138	Placebo Vaginal Cream n = 65
Value	49	51	1

Estradiol Vaginal Cream vs Placebo Vaginal Cream: Difference: 0.3766 (95% CI 0.2743 to 0.4790), p <0.0001, Chi-squared
Estrace® 0.01% Cream vs Placebo Vaginal Cream: Difference: 0.3542 (95% CI 0.2570 to 0.4514), p <0.0001, Chi-squared

Population analysed: The Intent-to-treat (ITT) population was used for the comparison of active treatments versus placebo analysis which consisted of all randomized subjects that used at least one dose of Test, Reference or Placebo and returned for at least one post-baseline visit.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estradiol Vaginal Cream	1 of 146 (0.7%)	31 of 146 (21.2%)	0 of 146
Estrace® 0.01% Cream	0 of 144 (0%)	27 of 144 (18.8%)	0 of 144
Placebo Vaginal Cream	0 of 72 (0%)	8 of 72 (11.1%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. N/A - Phase I study

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.

Matt Hummel, Ph.D. study chair

Mylan Pharmaceuticals Inc

Ronald Ackerman, M.D. principal investigator

Comprehensive Clinical Trials, LLC

James Andersen, M.D. principal investigator

Meridien Research

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estradiol Vaginal Cream, 0.01% and Estrace® 0.01% cream in people with Atrophic Vaginitis, run by Mylan Pharmaceuticals Inc at 21 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 30 inclusion and 45 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 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 6 Sep 2017). 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?

Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence (time frame: Study Day 8). The study lists 2 primary outcomes in all. 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 NCT02195986.

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 9 Mar 2022.