Atrophic VaginitisPhase 3NCT02995694
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
A Phase 3 study testing Estradiol and Reference in people with Atrophic Vaginitis, run by Alvogen Pine Brook LLC.
Trial summary
The purpose of this study is to determine the therapeutic equivalence of Alvogen'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 30 to 75 years, women only
- Conditions the study is for
- Atrophic Vaginitis
- What is being tested?
- Estradiol and Reference
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 535 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- 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 that meets all criteria of current FDA regulations
- Females age: 30-75 years old inclusive who are postmenopausal.
- 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. Hysterectomy without oophorectomy if of age that investigator believes would have naturally reached 12 months of spontaneous amenorrhea.
- Baseline evaluation requirements:
- ≤5% superficial cells on vaginal smear cytology
- Vaginal pH > 5.0
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- 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)* *provided that patient is currently sexually active and plans to remain so throughout study.
- Normal breast exam at screening and mammogram completed within 9 months prior to screening in patients >40 years old.
- For women with an intact uterus, an endometrial thickness < 4 mm as determined by vaginal ultrasonography.
- Documented PAP smear conducted within previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol
Who cannot join
- Females younger than 30 years of age or older than 75 years of age
- Patients with a serum FSH level of ≤ 40mIU/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 patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- Patients with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Patients with an endometrial thickness equal to or greater than 4mm should be excluded.
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- Patients with known, suspected or current history of carcinoma of the breast. All patients over the age of 40 must have had a mammogram performed within 9 months of the study start and all patients will have a physical breast exam performed at screening.
- Patients with baseline systolic blood pressure of > 150mm Hg and/or diastolic pressure > 90 mm Hg
- Any patient with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
- Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).
About this study
Official title: Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Alvogen'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 the detailed description
This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo.
Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.
Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows:
- Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)
- Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)
- Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)
Patients completed up to three clinic visits as follows:
- Visit 1 - Screening: Day -14 to Day -1
- Visit 2 - Randomization: Day 1
- Visit 3 - End of Study: Day 8, maximum Day 10
Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.
- Conditions
- Atrophic Vaginitis
- Being tested
- Estradiol, Placebos, Reference
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called Estadiol Vaginal Cream
Estradiol Vaginal Cream
PlacebosDrug
Also called Topical Vaginal Cream
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
ReferenceDrug
Also called Topical Vaginal Cream
Estrace Vaginal Cream
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Estradiol Vaginal Cream Receives: Drug: Estradiol |
| Reference. | Active comparator | Estrace Vaginal Cream Receives: Drug: Reference |
| Placebos | Placebo comparator | Placebo with no active pharmaceutical ingredients. Topical vaginal cream Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Cytology
Number of patients in PP population identified as responders at end of the study.
Measured: Day 8
Secondary outcomes (1)
Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy
Number of participants with the most bothersome vulvar and/or vaginal atrophy symptom treatment success at end of study. A "Treatment Success" was defined as a score of 0 or 1 at Day 8 (maximum Day 10) for the symptom identified at baseline as the most bothersome. This evaluation was based on patient self-assessed symptoms of VVA on a scale of 0 to 3 where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Pine Brook LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meena Venugopal, Ph.D., Study chair, Alvogen Pine Brook LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995694
- Sponsor's protocol ID
- 71462901
- Status last verified
- Nov 2021
- First submitted
- 14 Dec 2016
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. 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%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT02995694
- Acronym / sponsor ID
- 71462901
- Conditions
- Atrophic Vaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Alvogen Pine Brook LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the therapeutic equivalence of Alvogen'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.
Detailed description
This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo.
Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.
Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows:
- Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)
- Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)
- Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)
Patients completed up to three clinic visits as follows:
- Visit 1 - Screening: Day -14 to Day -1
- Visit 2 - Randomization: Day 1
- Visit 3 - End of Study: Day 8, maximum Day 10
Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: EstradiolEstradiol Vaginal Cream |
| Reference. | Active comparator | Drug: ReferenceEstrace Vaginal Cream |
| Placebos | Placebo comparator | Drug: PlacebosPlacebo with no active pharmaceutical ingredients. Topical 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 (15 listed)
- Signed Informed Consent that meets all criteria of current FDA regulations
- Females age: 30-75 years old inclusive who are postmenopausal.
- 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. Hysterectomy without oophorectomy if of age that investigator believes would have naturally reached 12 months of spontaneous amenorrhea.
- Baseline evaluation requirements:
- Normal breast exam at screening and mammogram completed within 9 months prior to screening in patients >40 years old.
Key exclusion criteria (10 listed)
- Females younger than 30 years of age or older than 75 years of age
- Patients with a serum FSH level of ≤ 40mIU/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 patient 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 |
|---|---|---|
| EstradiolAlso: Estadiol Vaginal CreamEstradiol Vaginal Cream | Drug | Test |
| PlacebosAlso: Topical Vaginal CreamPlacebo with no active pharmaceutical ingredients. Topical vaginal cream | Drug | Placebos |
| ReferenceAlso: Topical Vaginal CreamEstrace Vaginal Cream | Drug | Reference. |
Primary outcome
Vaginal Cytology
Time frame: Day 8
Number of patients in PP population identified as responders at end of the study.
1 secondary outcome
Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy
Time frame: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- 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.
Meena Venugopal, Ph.D. study chair
Alvogen Pine Brook LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol and Reference in people with Atrophic Vaginitis, run by Alvogen Pine Brook LLC.
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 15 inclusion and 10 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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 1 Dec 2021). 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?
Vaginal Cytology (time frame: Day 8). 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 1 Dec 2021.