Vulvar AtrophyPhase 3NCT01753102
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
A Phase 3 study testing Estradiol in people with Vulvar Atrophy and Vaginal Atrophy, run by Sun Pharmaceutical Industries Limited at 1 site in India.
Trial summary
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vulvar Atrophy, Vaginal Atrophy
- What is being tested?
- Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteIndia
- Study dates
- 6 Nov 2012to 30 Apr 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal woman
- At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
- ≤ 5% superficial cells on vaginal smear cytology
- Vaginal pH > 5.0
Who cannot join
- Consumption of estrogen alone or estrogen/progestin containing drug products.
- Allergy to estradiol or related products
- History of breast cancer and significant risk factors for endometrial cancer
- Abnormal genital bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.
The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.
The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.
Read the detailed description
Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.
This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.
The patients will be administered with one tablet intravaginally daily for 14 days.
- Conditions
- Vulvar Atrophy, Vaginal Atrophy
- Being tested
- Estradiol
- Keywords
- Estradiol, Vulvar atrophy, vaginal atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called Vagifem
one tablet will be inserted daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Estradiol | Experimental | Intravaginal self-administration of study medication once daily for 14 days. Receives: Drug: Estradiol |
| Reference: Estradiol | Active comparator | Intravaginal self-administration of study medication once daily for 14 days. Receives: Drug: Estradiol |
| Placebo | Placebo comparator | Intravaginal self-administration of study medication once daily for 14 days. Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal pH
Measured: 14 days
Secondary outcomes (1)
Symptoms of vulvar and vaginal atrophy
Each subject will specify identified most bothersome symptoms vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity, vaginal bleeding associated with sexual activity) and self-evaluate the symptom on a pre-defined scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study start6 Nov 2012
- Primary completion30 Apr 2013
- Study completion30 Apr 2013
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753102
- Sponsor's protocol ID
- CLR_10_19
- Other IDs
- CTRI/2012/09/002983
- Status last verified
- Oct 2018
- First submitted
- 15 Dec 2012
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY
- ClinicalTrials.gov ID
- NCT01753102
- Acronym / sponsor ID
- CLR_10_19
- Conditions
- Vulvar Atrophy, Vaginal Atrophy
- Keywords
- Estradiol, Vulvar atrophy, vaginal atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2012 (actual)
- Primary completion
- 30 Apr 2013 (actual)
- Study completion
- 30 Apr 2013 (actual)
- First posted
- 20 Dec 2012 (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.
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.
The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.
The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.
Detailed description
Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.
This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.
The patients will be administered with one tablet intravaginally daily for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estradiol | Experimental | Drug: EstradiolIntravaginal self-administration of study medication once daily for 14 days. |
| Reference: Estradiol | Active comparator | Drug: EstradiolIntravaginal self-administration of study medication once daily for 14 days. |
| Placebo | Placebo comparator | Drug: EstradiolIntravaginal self-administration of study medication once daily for 14 days. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal woman
- At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
- ≤ 5% superficial cells on vaginal smear cytology
- Vaginal pH > 5.0
Key exclusion criteria (4 listed)
- Consumption of estrogen alone or estrogen/progestin containing drug products.
- Allergy to estradiol or related products
- History of breast cancer and significant risk factors for endometrial cancer
- Abnormal genital bleeding
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: Vagifemone tablet will be inserted daily for 14 days | Drug | Estradiol, Placebo, Reference: Estradiol |
Primary outcome
Vaginal pH
Time frame: 14 days
1 secondary outcome
Symptoms of vulvar and vaginal atrophy
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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 Estradiol in people with Vulvar Atrophy and Vaginal Atrophy, run by Sun Pharmaceutical Industries Limited at 1 site in India.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Oct 2018. 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 India. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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 pH (time frame: 14 days). 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 9 Oct 2018.