Vulvar and Vaginal AtrophyPhase 3NCT02668796
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
A Phase 3 study testing Estradiol Vaginal Tablets 10 mcg (Glenmark) and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) in people with Vulvar and Vaginal Atrophy, run by Glenmark Pharmaceuticals Ltd. India at 1 site in United States.
Trial summary
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar and Vaginal Atrophy
- What is being tested?
- Estradiol Vaginal Tablets 10 mcg (Glenmark) and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 522 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 21 Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female postmenopausal subjects aged >30 to <75 years
- At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her
- vaginal dryness
- vaginal and/or vulvar irritation/ itching
- dysuria
- vaginal pain associated with sexual activity
Show all 9Show fewer
- presence of vaginal bleeding associated with sexual activity
- Have <5% superficial cells on vaginal smear cytology and vaginal pH >5.0 at Visit 1
- Systolic blood pressure <150mm Hg and diastolic blood pressure <90mm Hg at Visit 1
Who cannot join
- Known hypersensitivity to Estradiol vaginal tablet
- Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
- History of undiagnosed vaginal bleeding.
- History of significant risk factors for endometrial cancer
- For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.
- Conditions
- Vulvar and Vaginal Atrophy
- Being tested
- Estradiol Vaginal Tablets 10 mcg (Glenmark), Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk), Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Vaginal Tablets 10 mcg (Glenmark)Drug
apply using the given applicator
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)Drug
apply using the given applicator
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)Drug
apply using the given applicator
| Study group | Role | What they receive |
|---|---|---|
| Estradiol Vaginal Tablets 10 mcg (Glenmark) | Experimental | apply using the given applicator Receives: Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark) |
| Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) | Active comparator | apply using the given applicator Receives: Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) |
| Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) | Placebo comparator | apply using the given applicator Receives: Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with at least 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: Day 15]
Secondary outcomes (1)
The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBS
Measured: Day 15]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion21 Sep 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Nikhil Sawant, Study director, Glenmark Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668796
- Sponsor's protocol ID
- GLK-1502
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.
- ClinicalTrials.gov ID
- NCT02668796
- Acronym / sponsor ID
- GLK-1502
- Conditions
- Vulvar and Vaginal Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estradiol Vaginal Tablets 10 mcg (Glenmark) | Experimental | Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark)apply using the given applicator |
| Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) | Active comparator | Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)apply using the given applicator |
| Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) | Placebo comparator | Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)apply using the given applicator |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female postmenopausal subjects aged >30 to <75 years
- At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her
- Have <5% superficial cells on vaginal smear cytology and vaginal pH >5.0 at Visit 1
- Systolic blood pressure <150mm Hg and diastolic blood pressure <90mm Hg at Visit 1
Key exclusion criteria (5 listed)
- Known hypersensitivity to Estradiol vaginal tablet
- Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
- History of undiagnosed vaginal bleeding.
- History of significant risk factors for endometrial cancer
- For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
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 Tablets 10 mcg (Glenmark)apply using the given applicator | Drug | Estradiol Vaginal Tablets 10 mcg (Glenmark) |
| Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)apply using the given applicator | Drug | Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) |
| Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)apply using the given applicator | Drug | Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) |
Primary outcome
The proportion of subjects with at least 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
Time frame: Day 15]
1 secondary outcome
The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBS
Time frame: Day 15]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Vulvar and Vaginal Atrophy
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Recruiting
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
Vulvar Atrophy, Vaginal Atrophy
Active, not recruiting
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
Vaginal Atrophy, Vulva; Atrophy
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.
Dr. Nikhil Sawant study director
Glenmark Pharmaceuticals Ltd.
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 Estradiol Vaginal Tablets 10 mcg (Glenmark) and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) in people with Vulvar and Vaginal Atrophy, run by Glenmark Pharmaceuticals Ltd. India 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 9 inclusion and 5 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 14 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 proportion of subjects with at least 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 (time frame: Day 15]). 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 14 Nov 2017.