Vulvar and Vaginal AtrophyPhase 3NCT03332303
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
A Phase 3 study testing Estrace® Cream and Estradiol Vaginal Cream in people with Vulvar and Vaginal Atrophy, run by Prasco LLC at 27 sites in United States.
Trial summary
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Vulvar and Vaginal Atrophy
- What is being tested?
- Estrace® Cream and Estradiol Vaginal Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 27 sitesUnited States
- Study dates
- 26 Oct 2017to 15 Mar 2018
- 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 IRB-approved informed consent form that meets all criteria of current FDA regulations.
- Postmenopausal females aged 30-75 years inclusive. Postmenopausal is defined as follows:
- At least 6 months of spontaneous amenorrhea.
- At least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy.
- Hysterectomy without oophorectomy if of age that the Investigator believes would have naturally reached 12 months of spontaneous amenorrhea if uterus had remained intact.
- Patients with a serum Follicle Stimulating Hormone (FSH) level of ≥ 40 mIU/mL at Screening.
Show all 19Show fewer
- Have ≤ 5% superficial cells on vaginal smear cytology.
- Have a vaginal pH > 5.0.
- At least one of the following patient self-assessed moderate to severe symptoms of VVA from the following list that is identified by the patient as being the most bothersome to her:
- Vaginal Dryness
- Vaginal and/or Vulvar Irritation/Itching
- Dysuria
- Vaginal Pain associated with sexual activity
- Vaginal Bleeding associated with sexual activity (presence or absence)
- Provided that patient is currently sexually active and plans to remain so throughout the study.
- Have "Normal" Screening mammogram completed within 9 months before Screening in all patients > 40 years old, with no findings that, in the opinion of the Investigator, would indicate any suspicion of breast malignancy.
- Normal clinical breast examination at Screening.
- Patients with an intact uterus (including patients who underwent a partial hysterectomy) must have a 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.
- Patients with an intact uterus should have vaginal ultrasonography results within 3 months before Screening to confirm an inactive endometrial lining, defined as endometrial thickness < 4 mm.
Who cannot join
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patient safety.
- Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis.
- Patients with active vaginal herpes simplex infection or have had an outbreak within 30 days before the Screening.
- Patients with known, suspected or current history of carcinoma of the breast.
- Patients with baseline systolic blood pressure of > 150 mmHg and/or diastolic pressure > 90 mmHg.
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- Any patient with past or current undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
- Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).
- Patients with known, suspected or current history of hormone dependent tumor.
- History of acute thrombophlebitis or thromboembolic disorder.
- Any prescription treatment for vaginal dryness/irritation within 14 days before Screening or any over-the-counter or natural remedies within 7 days before Screening.
- Any prescription treatment for bacterial or yeast infections within 30 days before Screening.
- Fasting triglyceride levels > 350 mg/dL.
- 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 patient.
- Patients who have used vaginal hormonal products (rings, creams, gels) within the 7 days before Screening.
- Patients who have used transdermal estrogen and/or progestin therapy within the 28 days before Screening.
- Patients who have used oral estrogen and/or progestin therapy or intrauterine progestin therapy within the 56 days before Screening.
- Patients who have used progestin implants or estrogen alone injectable drug therapy within the 3 month before Screening.
- Patients who have used estrogen pellet therapy or progestin injectable drug therapy within 6 months before Screening.
- History of significant alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months before Screening (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- History of significant drug abuse within 1 year prior to Screening, use of soft drugs (such as marijuana) within 3 months before Screening, or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year before Screening.
- Use within 30 days of Screening with known strong CYP3A4 inducers or inhibitors that, in the opinion of the Investigator, may affect estrogen metabolism. Examples of strong CYP3A4 inhibitors are macrolide antibiotics such as clarithromycin and telithromycin; azole antifungals such as itraconazole and ketoconazole; antidepressants such as nefazodone; and foods such as grapefruit or grapefruit juice. Examples of strong CYP3A4 inducers are anticonvulsants such as carbamazepine and phenytoin; bactericidals such as rifampin and rifabutin; and natural health products such as St. John's wort.
- Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
- Receipt of any drug as part of a research study within 30 days before Screening.
- Employees of the Investigator or research center or their immediate family members.
- Patients who have participated in this study previously.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Canton Obstetrics and Gynecology
Canton, Michigan, 48187
Aventiv Research, Inc.
Columbus, Ohio, 43213
Vernon & Waldrep OBGYN Associates
Dallas, Texas, 75230
Avail Clinical Research, LLC
DeLand, Florida, 32720
Downtown Women's Health Care
Denver, Colorado, 80209
Health Awareness, Inc.
Jupiter, Florida, 33458
Beyer Research
Kalamazoo, Michigan, 49009
Lawrence Ob-Gyn Clinical Research, LLC
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510
Praetorian Pharmaceutical
Marrero, Louisiana, 70072
Southern Clinical Research Associates
Metairie, Louisiana, 70001
New Age Medical Research Corporation
Miami, Florida, 33186
Panax Clinical Research
Miami Lakes, Florida, 33014
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Suncoast Clinical Research
New Port Richey, Florida, 34652
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Novum PRS
Pittsburgh, Pennsylvania, 15219
Health Awareness, Inc.
Port Saint Lucie, Florida, 34952
Douglas Young, MD
Sacramento, California, 95821
Medical Center for Clinical Research
San Diego, California, 92108
Women's Health Care Research Corp.
San Diego, California, 92111
Physician Care Clinical Research, LLC
Sarasota, Florida, 34239
Women's Clinical Research Center dba Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105
Well Pharma Medical Research Group
South Miami, Florida, 33143
Meridien Research, Inc.
St. Petersburg, Florida, 33709
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.
- Conditions
- Vulvar and Vaginal Atrophy
- Being tested
- Estrace® Cream, Estradiol Vaginal Cream, Vehicle Cream
- Keywords
- Vaginal Dryness, Vaginal and/or Vulvar Irritation/Itching, Dysuria, Vaginal Pain and Bleeding
- Medical subject headings
- Pruritus, Dysuria, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrace® CreamDrug
Also called Estradiol Vaginal Cream
Estrace® Cream
Estradiol Vaginal CreamDrug
Estradiol Vaginal Cream
Vehicle CreamDrug
Also called Placebo
Vehicle Cream
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) | Experimental | Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01% Receives: Drug: Estradiol Vaginal Cream |
| Active Comparator: Estrace® Cream | Active comparator | Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%) Receives: Drug: Estrace® Cream |
| Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream | Placebo comparator | Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Endpoint
The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant 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. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Measured: Study Day 8 or Study Day 9
Secondary outcomes (1)
The Secondary Efficacy Endpoint
The secondary efficacy endpoint is the number of participants in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 8 or Day 9. A "Treatment Success" is defined as a score of 0 or 1 on Day 8 or Day 9 for the symptom identified at baseline as the most bothersome. This evaluation will be based on (one) participant self-assessed symptom of VVA (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, or vaginal pain associated with sexual activity) on a scale of 0 to 3 where 0 = none and 3 = severe. Evaluation of vaginal bleeding during sexual activity will be based on a score of 1 (presence) if it is identified by the participant as the most bothersome symptom at baseline and a score of 0 (absent) on Day 8 or Day 9.
Measured: Study Day 8 or Study Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start26 Oct 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
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 Vulvar and Vaginal AtrophyStudies 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
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prasco LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Gongas, Study director, Novum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332303
- Sponsor's protocol ID
- 71759501
- Status last verified
- Mar 2024
- First submitted
- 1 Nov 2017
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy
- ClinicalTrials.gov ID
- NCT03332303
- Acronym / sponsor ID
- 71759501
- Conditions
- Vulvar and Vaginal Atrophy
- Keywords
- Vaginal Dryness, Vaginal and/or Vulvar Irritation/Itching, Dysuria, Vaginal Pain and Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Prasco LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 30 May 2024
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 are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.
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 |
|---|---|---|
| Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) | Experimental | Drug: Estradiol Vaginal CreamEstradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days. Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01% |
| Active Comparator: Estrace® Cream | Active comparator | Drug: Estrace® CreamEstrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days. Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%) |
| Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream | Placebo comparator | Drug: Vehicle CreamPlacebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days. Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed IRB-approved informed consent form that meets all criteria of current FDA regulations.
- Postmenopausal females aged 30-75 years inclusive. Postmenopausal is defined as follows:
- Patients with a serum Follicle Stimulating Hormone (FSH) level of ≥ 40 mIU/mL at Screening.
- Have ≤ 5% superficial cells on vaginal smear cytology.
- Have a vaginal pH > 5.0.
Key exclusion criteria (27 listed)
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patient safety.
- Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis.
- Patients with active vaginal herpes simplex infection or have had an outbreak within 30 days before the Screening.
- Patients with known, suspected or current history of carcinoma of the breast.
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 |
|---|---|---|
| Estrace® CreamAlso: Estradiol Vaginal CreamEstrace® Cream | Drug | Active Comparator: Estrace® Cream |
| Estradiol Vaginal CreamEstradiol Vaginal Cream | Drug | Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) |
| Vehicle CreamAlso: PlaceboVehicle Cream | Drug | Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream |
Primary outcome
The Primary Efficacy Endpoint
Time frame: Study Day 8 or Study Day 9
The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant 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. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
1 secondary outcome
The Secondary Efficacy Endpoint
Time frame: Study Day 8 or Study Day 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- 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.
Gail Gongas study director
Novum
27 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 Estrace® Cream and Estradiol Vaginal Cream in people with Vulvar and Vaginal Atrophy, run by Prasco LLC at 27 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 19 inclusion and 27 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 30 May 2024). 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?
The Primary Efficacy Endpoint (time frame: Study Day 8 or Study Day 9). 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 30 May 2024.