Atrophic VaginitisPhase 3NCT03294538
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
A Phase 3 study testing Generic Estradiol Vaginal Cream USP, 0.01% and Estrace® Vaginal Cream USP, 0.01% in people with Atrophic Vaginitis, run by Actavis Inc. at 44 sites in United States.
Trial summary
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Atrophic Vaginitis
- What is being tested?
- Generic Estradiol Vaginal Cream USP, 0.01% and Estrace® Vaginal Cream USP, 0.01%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 663 participants
- Where
- 44 sitesUnited States
- Study dates
- 18 May 2016to 15 Feb 2017
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations.
- Females aged 30-75 years inclusive who are postmenopausal, defined as follows:
- At least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) level of >40 milli-international units per milliliter (mIU/mL); at least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy; or hysterectomy without oophorectomy if of age that the Investigator believes would have been naturally reached 12 months of spontaneous amenorrhea.
- Vaginal pH >5.0.
- At least 1 of the following participant self-assessed moderate to severe symptoms of vulvar and vaginal atrophy (VVA) from the following list that is identified by the participant as being most bothersome to her:
- Vaginal Dryness
Show all 13Show fewer
- Vaginal and/or vulvar irritation/itching
- Dysuria
- Vaginal pain or bleeding associated with sexual activity, provided that participant is currently sexually active and plans to remain so throughout study.
- "Normal" Screening mammogram completed within 9 months prior to Screening in all participants >40 years old.
- Normal clinical breast examination at the Screening Visit.
- Documented papanicolaou (PAP) smear conducted within the previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
- Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining, defined as endometrial thickness less than 4 millimeters (mm).
Who cannot join
- Females younger than 30 years of age or older than 75 years of age.
- Participants with a Serum follicle-stimulating hormone (FSH) level of ≤40 mIU/mL at Screening.
- Greater than 5% superficial cells on vaginal cytology.
- Vaginal pH ≤5.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study participant at undue risk by participation or could jeopardize the integrity of the study evaluations.
- Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Participants with an endometrial thickness equal to or greater than 4 mm.
Show all 30Show fewer
- Documented PAP smear conducted within the previous 12 months with findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
- Participants with known concurrent vaginal infections including but not limited to:
- Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or Gardnerella vaginalis.
- Participants with active vaginal herpes simplex infection or have had an outbreak within 30 days of the first dosing day.
- Participants with known, suspected, or current history of carcinoma of the breast. All participants over the age of 40 must have had a mammogram performed within 9 months of the study start and all participants will have a physical breast exam performed at Screening.
- Participants with known, suspected or current history of hormone dependent tumor.
- Participants with baseline systolic blood pressure of >150 millimetres of mercury (mmHg) and/or diastolic pressure >90 mmHg.
- Any participant with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
- Any history of estrogen-dependent neoplasia (for example, endometrial cancer).
- History of acute thrombophlebitis or thromboembolic disorder.
- Any current or recent (within the previous 6 months) genital bleeding of unknown etiology.
- Any prescription treatment or over-the-counter (OTC) or natural remedies for vaginal dryness/irritation within 28 days of Screening. Products used for lubrication during sexual intercourse within 7 days of Screening.
- Participants whose fasting triglyceride levels are greater than 350 mg/dL.
- Any participant with a history of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
- Any known or suspected allergies that in the Investigator's opinion would compromise the safety of the participant.
- Participants who have used vaginal hormonal products (rings, creams, gels) within the 28 days prior to Screening.
- Any participant who has used transdermal estrogen and/or progestin therapy within the 28 days prior to Screening.
- Participants who have used oral estrogen and/ or progestin therapy or intrauterine progestin therapy within the 56 days prior to Screening.
- Participants who have used progestin implants or estrogen alone injectable drug therapy within the 3 months before Screening.
- Participants who have used estrogen pellet therapy or progestin injectable drug therapy within the 6 months before Screening.
- Participants who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
- Participants who are unable or unwilling to give informed consent.
- Receipt of any drug as part of a research study within 30 days prior to Screening.
- Participants who have participated in this study previously.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Site Number 23
Bluffton, South Carolina, 29910
Site Number 25
Colorado Springs, Colorado, 80923
Site Number 07
Columbus, Ohio, 43213
Site Number 32
Dallas, Texas, 75230
Site Number 01
Denver, Colorado, 80209
Site Number 14
Denver, Colorado, 80220
Site Number 24
Englewood, Ohio, 45322
Site Number 06
Jupiter, Florida, 33458
Site Number 16
Kalamazoo, Michigan, 49009
Site Number 31
La Mesa, California, 91942
Site Number 13
Lake Worth, Florida, 33461
Site Number 12
Lawrenceville, New Jersey, 08648
Site Number 35
Lincoln, Nebraska, 68510
Site Number 33
Metairie, Louisiana, 70001
Site Number 27
Miami, Florida, 33015
Site Number 40
Miami, Florida, 33130
Site Number 20
Miami, Florida, 33136
Site Number 39
Miami, Florida, 33144
Site Number 38
Miami, Florida, 33186
Site Number 30
Miami Lakes, Florida, 33014
Site Number 41
Mt. Pleasant, South Carolina, 29464
Site Number 43
Myrtle Beach, South Carolina, 29572
Site Number 18
New London, Connecticut, 06320
Site Number 08
New Port Richey, Florida, 34652
Site Number 03
Ormond Beach, Florida, 32174
Site Number 26
Plainsboro, New Jersey, 08536
Site Number 45
Port Saint Lucie, Florida, 34952
Site Number 36
Raleigh, North Carolina, 27607
Site Number 29
Roswell, Georgia, 30075
Site Number 11
Sacramento, California, 95821
Site Number 34
Saginaw, Michigan, 48604
Site Number 05
San Diego, California, 91208
Site Number 15
San Diego, California, 92111
Site Number 10
Sarasota, Florida, 34239
Site Number 22
Savannah, Georgia, 31406
Site Number 09
Seattle, Washington, 98105
Site Number 19
St. Petersburg, Florida, 33709
Site Number 44
Tucson, Arizona, 85710
Site Number 17
Tucson, Arizona, 85712
Site Number 28
West Chester, Ohio, 45069
Site Number 02
West Palm Beach, Florida, 33409
Site Number 21
Wichita, Kansas, 67226
Site Number 04
Winston-Salem, North Carolina, 27103
Site Number 37
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.
Read the detailed description
Systemic (oral or transdermal patch administration) estrogen therapies have been shown to effectively treat symptoms of atrophic vaginitis but bear undesirable side effects including increased risk of heart attacks, stroke, endometrial cancer, and breast cancer. Topical therapies (creams and transvaginal delivery systems) provide low doses of estrogen to the vaginal mucosa to provide local relief for the symptoms of atrophic vaginitis, while reducing the unwanted side effects associated with systemic delivery systems. Low dose, topical estrogen therapy is considered most appropriate and convenient for the treatment of vaginal symptoms associated with menopause, particularly when other symptoms including bone loss or vasomotor dysfunction do not need to be targeted.
- Conditions
- Atrophic Vaginitis
- Being tested
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Estradiol Vaginal Cream USP, 0.01%Drug
Vaginal cream, generic formulation of the brand product.
Estrace® Vaginal Cream USP, 0.01%Drug
Vaginal cream, brand product.
Vehicle Vaginal CreamDrug
Vaginal cream, placebo. Has no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | Experimental | Participants were to self-administer 2 grams (g) of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. Receives: Drug: Generic Estradiol Vaginal Cream USP, 0.01% |
| Estrace Vaginal Cream USP, 0.01% | Active comparator | Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. Receives: Drug: Estrace® Vaginal Cream USP, 0.01% |
| Vehicle Vaginal Cream | Placebo comparator | Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days. Receives: Drug: Vehicle Vaginal Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Measured: Up to Day 9
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.
Measured: Up to Day 9
Secondary outcomes (2)
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Measured: Up to Day 9
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start18 May 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
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
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Teva Pharmaceuticals USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294538
- Sponsor's protocol ID
- 71436001
- Status last verified
- Dec 2019
- First submitted
- 20 Sep 2017
- Last updated
- 26 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT03294538
- Acronym / sponsor ID
- 71436001
- Conditions
- Atrophic Vaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 18 May 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.
Detailed description
Systemic (oral or transdermal patch administration) estrogen therapies have been shown to effectively treat symptoms of atrophic vaginitis but bear undesirable side effects including increased risk of heart attacks, stroke, endometrial cancer, and breast cancer. Topical therapies (creams and transvaginal delivery systems) provide low doses of estrogen to the vaginal mucosa to provide local relief for the symptoms of atrophic vaginitis, while reducing the unwanted side effects associated with systemic delivery systems. Low dose, topical estrogen therapy is considered most appropriate and convenient for the treatment of vaginal symptoms associated with menopause, particularly when other symptoms including bone loss or vasomotor dysfunction do not need to be targeted.
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 |
|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | Experimental | Drug: Generic Estradiol Vaginal Cream USP, 0.01%Participants were to self-administer 2 grams (g) of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. |
| Estrace Vaginal Cream USP, 0.01% | Active comparator | Drug: Estrace® Vaginal Cream USP, 0.01%Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. |
| Vehicle Vaginal Cream | Placebo comparator | Drug: Vehicle Vaginal CreamParticipants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations.
- Females aged 30-75 years inclusive who are postmenopausal, defined as follows:
- At least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) level of >40 milli-international units per milliliter (mIU/mL); at least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy; or hysterectomy without oophorectomy if of age that the Investigator believes would have been naturally reached 12 months of spontaneous amenorrhea.
- Vaginal pH >5.0.
- At least 1 of the following participant self-assessed moderate to severe symptoms of vulvar and vaginal atrophy (VVA) from the following list that is identified by the participant as being most bothersome to her:
Key exclusion criteria (30 listed)
- Females younger than 30 years of age or older than 75 years of age.
- Participants with a Serum follicle-stimulating hormone (FSH) level of ≤40 mIU/mL at Screening.
- Greater than 5% superficial cells on vaginal cytology.
- Vaginal pH ≤5.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study participant at undue risk by participation or could jeopardize the integrity of the study evaluations.
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 |
|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01%Vaginal cream, generic formulation of the brand product. | Drug | Generic Estradiol Vaginal Cream USP, 0.01% |
| Estrace® Vaginal Cream USP, 0.01%Vaginal cream, brand product. | Drug | Estrace Vaginal Cream USP, 0.01% |
| Vehicle Vaginal CreamVaginal cream, placebo. Has no active ingredient | Drug | Vehicle Vaginal Cream |
Primary outcome
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
Time frame: Up to Day 9
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
Time frame: Up to Day 9
Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent 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
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
Time frame: Up to Day 9
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
Time frame: Up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Teva Pharmaceuticals USA
44 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 Generic Estradiol Vaginal Cream USP, 0.01% and Estrace® Vaginal Cream USP, 0.01% in people with Atrophic Vaginitis, run by Actavis Inc. at 44 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 13 inclusion and 30 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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 26 Dec 2019). 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?
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups (time frame: Up to Day 9). 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?
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 26 Dec 2019.