AtrophyPhase 3NCT00276094

A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

A Phase 3 study testing Ospemifene 30 mg, Ospemifene 60 mg and Nonhormonal vaginal lubricant in people with Atrophy and Vaginal Diseases, run by Shionogi.

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

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women. Read more about this study

Who is it for?: Ages 40 to 80 years, women only
Conditions the study is for: Atrophy, Vaginal Diseases
What is being tested?: Ospemifene 30 mg, Ospemifene 60 mg and Nonhormonal vaginal lubricant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 826 participants
Where: No sites listed yet
Study dates: Jan 2006to Dec 2007
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 40 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Naturally or surgically postmenopausal
Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Who cannot join

Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
Abnormal Pap smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication

About this study

Official title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Conditions: Atrophy, Vaginal Diseases
Being tested: Ospemifene 30 mg, Ospemifene 60 mg, Placebo, Nonhormonal vaginal lubricant
Keywords: Urogenital atrophy, Vaginal atrophy, Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms
Medical subject headings: Atrophy, Vaginal Diseases

What participants receive

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

Ospemifene 30 mgDrug
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Ospemifene 60 mgDrug
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
PlaceboDrug
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Nonhormonal vaginal lubricantDrug
Also called K-Y® Brand Jelly
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Study groups in NCT00276094
Study group	Role	What they receive
Ospemifene 30 mg/day and nonhormonal vaginal lubricant	Experimental	Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Receives: Drug: Ospemifene 30 mg; Drug: Nonhormonal vaginal lubricant
Ospemifene 60 mg/day and nonhormonal vaginal lubricant	Experimental	Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Receives: Drug: Ospemifene 60 mg; Drug: Nonhormonal vaginal lubricant
Placebo tablets and nonhormonal vaginal lubricant	Placebo comparator	Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Receives: Drug: Placebo; Drug: Nonhormonal vaginal lubricant

What is being measured

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

Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: Baseline (Randomization) to Week 12
Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: Baseline (Randomization) to Week 12
Mean Change From Baseline in Vaginal pH
Measured: Baseline (Screening) to Week 12
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
Measured: Baseline (Screening) to Week 12
Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
Measured: Baseline (Screening) to Week 12

Secondary outcomes (9)

Change From Baseline in Visual Evaluation of the Vagina
Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: Baseline (Screening) to Week 12
Change From Baseline in Severity of VVA Symptoms
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: Baseline (Randomization) to Week 12
Change From Baseline in Estradiol Levels
Measured: Baseline (Screening) to Week 12
Change From Baseline in Follicle Stimulating Hormone Levels
Measured: Baseline (Screening) to Week 12
Change From Baseline in Luteinizing Hormone Levels
Measured: Baseline (Screening) to Week 12
Change From Baseline in Sex Hormone Binding Globulin Levels
Measured: Baseline (Screening) to Week 12
Change From Baseline in Testosterone (Free) Levels
Measured: Baseline (Screening) to Week 12
Change From Baseline in Testosterone (Total) Levels
Measured: Baseline (Screening) to Week 12
Change From Baseline in Urinary Symptoms
Measured: Baseline (Randomization) to Week 12

Timeline

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

Jan 2006Dec 2007

First posted12 Jan 2006 (estimated)
Study startJan 2006
Study completionDec 2007

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.
More trials run by ShionogiThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 826 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00276094
Sponsor's protocol ID: 15-50310
Status last verified: Mar 2013
First submitted: 10 Jan 2006
Last updated: 28 Jun 2013
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo
ClinicalTrials.gov ID: NCT00276094
Acronym / sponsor ID: 15-50310
Conditions: Atrophy, Vaginal Diseases
Keywords: Urogenital atrophy, Vaginal atrophy, Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 826 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Collaborators: Hormos Medical, QuatRx Pharmaceuticals
Study start: Jan 2006
Study completion: Dec 2007 (actual)
First posted: 12 Jan 2006 (estimated)
Results: Posted 28 Jun 2013

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 whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Study design

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

Arm	Type	Receives
Ospemifene 30 mg/day and nonhormonal vaginal lubricant	Experimental	Drug: Ospemifene 30 mg, Drug: Nonhormonal vaginal lubricantSubjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Ospemifene 60 mg/day and nonhormonal vaginal lubricant	Experimental	Drug: Ospemifene 60 mg, Drug: Nonhormonal vaginal lubricantSubjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Placebo tablets and nonhormonal vaginal lubricant	Placebo comparator	Drug: Placebo, Drug: Nonhormonal vaginal lubricantSubjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

Who may qualify

Ages: 40 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Naturally or surgically postmenopausal
Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Key exclusion criteria (4 listed)

Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
Abnormal Pap smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication

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
Ospemifene 30 mg1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).	Drug	Ospemifene 30 mg/day and nonhormonal vaginal lubricant
Ospemifene 60 mg1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).	Drug	Ospemifene 60 mg/day and nonhormonal vaginal lubricant
Placebo1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).	Drug	Placebo tablets and nonhormonal vaginal lubricant
Nonhormonal vaginal lubricantAlso: K-Y® Brand JellySubjects should apply the vaginal lubricant as needed and record the usage in the medication diary.	Drug	Ospemifene 30 mg/day and nonhormonal vaginal lubricant, Ospemifene 60 mg/day and nonhormonal vaginal lubricant, Placebo tablets and nonhormonal vaginal lubricant

Primary outcome

Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
Time frame: Baseline (Randomization) to Week 12
This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
Time frame: Baseline (Randomization) to Week 12
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Mean Change From Baseline in Vaginal pH
Time frame: Baseline (Screening) to Week 12
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
Time frame: Baseline (Screening) to Week 12
Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
Time frame: Baseline (Screening) to Week 12

9 secondary outcomes

Change From Baseline in Visual Evaluation of the Vagina
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Severity of VVA Symptoms
Time frame: Baseline (Randomization) to Week 12
Change From Baseline in Estradiol Levels
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Follicle Stimulating Hormone Levels
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Luteinizing Hormone Levels
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Sex Hormone Binding Globulin Levels
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Testosterone (Free) Levels
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Testosterone (Total) Levels
Time frame: Baseline (Screening) to Week 12
Change From Baseline in Urinary Symptoms
Time frame: Baseline (Randomization) to Week 12

Results and safety

Results posted to the registry on 28 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant	282	225
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant	276	234
Placebo Tablets and Nonhormonal Vaginal Lubricant	268	230

Primary outcome: Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness

Time frame: Baseline (Randomization) to Week 12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant n = 102	Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant n = 118	Placebo Tablets and Nonhormonal Vaginal Lubricant n = 104
Value	-1.22 (0.929)	-1.26 (1.025)	-0.84 (0.996)

Primary outcome: Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity

Time frame: Baseline (Randomization) to Week 12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant n = 136	Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant n = 120	Placebo Tablets and Nonhormonal Vaginal Lubricant n = 122
Value	-1.02 (1.132)	-1.19 (1.292)	-0.89 (1.115)

Primary outcome: Mean Change From Baseline in Vaginal pH

Time frame: Baseline (Screening) to Week 12. Mean (Standard Deviation). Unit: pH

Measure	Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant n = 282	Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant n = 276	Placebo Tablets and Nonhormonal Vaginal Lubricant n = 268
Value	-0.67 (1.054)	-1.01 (1.053)	-0.096 (0.8357)

Primary outcome: Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear

Time frame: Baseline (Screening) to Week 12. Mean (Standard Deviation). Unit: percentage of parabasal cells

Measure	Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant n = 280	Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant n = 276	Placebo Tablets and Nonhormonal Vaginal Lubricant n = 268
Value	-21.9 (32.60)	-30.1 (37.93)	3.98 (35.205)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks (Visit 2 [Randomization] to Visit 5). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant	5 of 282 (1.8%)	99 of 282 (35.1%)	Not reported
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant	0 of 276 (0%)	99 of 276 (35.9%)	Not reported
Placebo Tablets and Nonhormonal Vaginal Lubricant	4 of 268 (1.5%)	49 of 268 (18.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ospemifene 30 mg, Ospemifene 60 mg and Nonhormonal vaginal lubricant in people with Atrophy and Vaginal Diseases, run by Shionogi.

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: finished, as of the sponsor's last update on 28 Jun 2013. 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 28 Jun 2013). 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?

Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness (time frame: Baseline (Randomization) to Week 12). The study lists 5 primary outcomes in all. 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 NCT00276094.

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 28 Jun 2013.