AtrophyPhase 3NCT02770365

Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

A Phase 3 study testing estrace cream (Perrigo) and estrace cream (Reference) in people with Atrophy, run by Padagis LLC at 1 site in United States.

Completed

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

Official record

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Trial summary

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy. Read more about this study

Who is it for?: Ages 30 to 75 years, women only
Conditions the study is for: Atrophy
What is being tested?: estrace cream (Perrigo) and estrace cream (Reference)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 695 participants
Where: 1 siteUnited States
Study dates: May 2016to Nov 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

postmenopausal female and otherwise healthy, 30 - 75 years of age.
≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
vaginal pH > 5.0 at Visit 1/Screening
Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Who cannot join

Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
Known or suspected estrogen-dependent neoplasia.
Has deep vein thrombosis, pulmonary embolism or history of these conditions.
Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.
Known acute or chronic hepatic disease or dysfunction

Trial locations and contacts

1 site in 1 country.

United States1 site

Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409

Other trials in United States

About this study

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Conditions: Atrophy
Being tested: estrace cream (Perrigo), estrace cream (Reference), Placebo cream
Medical subject headings: Atrophy

What participants receive

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

estrace cream (Perrigo)Drug
Also called Perrigo product
estrace cream (Reference)Drug
Also called Reference Listed Drug product
Placebo creamDrug

Study groups in NCT02770365
Study group	Role	What they receive
Test Product	Experimental	estradiol cream Receives: Drug: estrace cream (Perrigo)
Reference Product	Active comparator	estradiol cream Receives: Drug: estrace cream (Reference)
Placebo product	Placebo comparator	Placebo cream Receives: Drug: Placebo cream

What is being measured

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

Percentage of Subjects Identified as Responders
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH < 5.0 with a change from Visit 1 of at least 0.5.
Measured: Day 8

Secondary outcomes (1)

Most Bothersome Symptom
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
Measured: Day 8

Timeline

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

May 2016Nov 2016

First posted12 May 2016 (estimated)
Study startMay 2016
Primary completionNov 2016
Study completionNov 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 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 695 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02770365
Sponsor's protocol ID: PRG-NY-15-007
Status last verified: Oct 2021
First submitted: 10 May 2016
Last updated: 2 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

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

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

Questions to ask the study team

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

See locations

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All Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
ClinicalTrials.gov ID: NCT02770365
Acronym / sponsor ID: PRG-NY-15-007
Conditions: Atrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 695 participants (actual)
Lead sponsor: Padagis LLCIndustry (pharma, biotech, devices)
Collaborators: Impax Laboratories, LLC
Study start: May 2016
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 12 May 2016 (estimated)
Results: Posted 11 Aug 2020

Clinical summary

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

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Test Product	Experimental	Drug: estrace cream (Perrigo)estradiol cream
Reference Product	Active comparator	Drug: estrace cream (Reference)estradiol cream
Placebo product	Placebo comparator	Drug: Placebo creamPlacebo cream

Who may qualify

Ages: 30 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

postmenopausal female and otherwise healthy, 30 - 75 years of age.
≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
vaginal pH > 5.0 at Visit 1/Screening
Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.

Key exclusion criteria (8 listed)

Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
Known or suspected estrogen-dependent neoplasia.

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 cream (Perrigo)Also: Perrigo product	Drug	Test Product
estrace cream (Reference)Also: Reference Listed Drug product	Drug	Reference Product
Placebo cream	Drug	Placebo product

Primary outcome

Percentage of Subjects Identified as Responders
Time frame: Day 8
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH < 5.0 with a change from Visit 1 of at least 0.5.

1 secondary outcome

Most Bothersome Symptom
Time frame: Day 8

Results and safety

Results posted to the registry on 11 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product	277	272
Reference Product	279	275
Placebo Product	139	139

Primary outcome: Percentage of Subjects Identified as Responders

Time frame: Day 8. Number. Unit: percentage of responders

Measure	Test Product n = 228	Reference Product n = 231	Placebo Product n = 121
Value	36.8	32.0	0.8

Test Product vs Reference Product: Equivalence ratio: 1.14 (90% CI -2.92 to 12.53), Wald's method

Population analysed: Per protocol population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 277 (0%)	0 of 277 (0%)	0 of 277
Reference Product	0 of 279 (0%)	0 of 279 (0%)	0 of 279
Placebo Product	0 of 139 (0%)	0 of 139 (0%)	0 of 139

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 4
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A Study of Bimagrumab in Participants With HFpEF
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Enrolling by invitationObservational study
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PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing estrace cream (Perrigo) and estrace cream (Reference) in people with Atrophy, run by Padagis LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2020). 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?

Percentage of Subjects Identified as Responders (time frame: Day 8). 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 NCT02770365.

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 2 Nov 2021.