AtrophyPhase 2NCT00630539

A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

A Phase 2 study testing Ospemifene 5 mg, Ospemifene 15 mg and Ospemifene 30 mg 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 the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II. 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 5 mg, Ospemifene 15 mg and Ospemifene 30 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: No sites listed yet
Study dates: Aug 2007to Feb 2008
Phase: Phase 2
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 menopausal
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Who cannot join

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal PAP smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

About this study

Official title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Conditions: Atrophy, Vaginal Diseases
Being tested: Placebo, Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg
Keywords: Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in postmenopausal women, Vaginal atrophy
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.

PlaceboDrug
1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Ospemifene 5 mgDrug
1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Ospemifene 15 mgDrug
1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Ospemifene 30 mgDrug
1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Study groups in NCT00630539
Study group	Role	What they receive
Subjects on placebo	Placebo comparator	Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks Receives: Drug: Placebo
Subjects on ospemifene 5 mg/day	Experimental	Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks Receives: Drug: Ospemifene 5 mg
Subjects on ospemifene 15 mg/day	Experimental	Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks Receives: Drug: Ospemifene 15 mg
Subjects on ospemifene 30 mg/day	Experimental	Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks Receives: Drug: Ospemifene 30 mg

What is being measured

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

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Measured: 12 weeks
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
Measured: 12 weeks
Mean Change From Baseline in Vaginal pH
Measured: 12 weeks

Secondary outcomes (8)

Visual Evaluation of Vagina (by Gynecological Examination)
Measured: Screening & Week 12
Mean Change From Baseline in Vaginal pH
Measured: Week 4
Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index
Measured: Week 4
Mean Change From Baseline in Estradiol Levels
Measured: Week 12
Mean Change From Baseline in Luteinizing Hormone Levels
Measured: Week 12
Mean Change From Baseline in Follicle Stimulating Hormone Levels
Measured: Week 12
Mean Change From Baseline in Sex Hormone Binding Globulin Levels
Measured: Week 12
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index
Measured: Week 4

Timeline

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

Aug 2007Feb 2008

First posted7 Mar 2008 (estimated)
Study startAug 2007
Primary completionJan 2008
Study completionFeb 2008

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630539
Sponsor's protocol ID: 15-50717
Status last verified: Mar 2013
First submitted: 28 Feb 2008
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 Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo
ClinicalTrials.gov ID: NCT00630539
Acronym / sponsor ID: 15-50717
Conditions: Atrophy, Vaginal Diseases
Keywords: Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in postmenopausal women, Vaginal atrophy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Collaborators: Hormos Medical, QuatRx Pharmaceuticals
Study start: Aug 2007
Primary completion: Jan 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 7 Mar 2008 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Subjects on placebo	Placebo comparator	Drug: PlaceboSubjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects on ospemifene 5 mg/day	Experimental	Drug: Ospemifene 5 mgSubjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects on ospemifene 15 mg/day	Experimental	Drug: Ospemifene 15 mgSubjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects on ospemifene 30 mg/day	Experimental	Drug: Ospemifene 30 mgSubjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Who may qualify

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

Key inclusion criteria (3 listed)

Naturally or surgically menopausal
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Key exclusion criteria (6 listed)

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal PAP smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications

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
Placebo1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).	Drug	Subjects on placebo
Ospemifene 5 mg1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).	Drug	Subjects on ospemifene 5 mg/day
Ospemifene 15 mg1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).	Drug	Subjects on ospemifene 15 mg/day
Ospemifene 30 mg1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).	Drug	Subjects on ospemifene 30 mg/day

Primary outcome

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Time frame: 12 weeks
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
Time frame: 12 weeks
Mean Change From Baseline in Vaginal pH
Time frame: 12 weeks

8 secondary outcomes

Visual Evaluation of Vagina (by Gynecological Examination)
Time frame: Screening & Week 12
Mean Change From Baseline in Vaginal pH
Time frame: Week 4
Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index
Time frame: Week 4
Mean Change From Baseline in Estradiol Levels
Time frame: Week 12
Mean Change From Baseline in Luteinizing Hormone Levels
Time frame: Week 12
Mean Change From Baseline in Follicle Stimulating Hormone Levels
Time frame: Week 12
Mean Change From Baseline in Sex Hormone Binding Globulin Levels
Time frame: Week 12
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index
Time frame: Week 4

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
Subjects on Placebo	34	33
Subjects on Ospemifene 5 mg/Day	33	29
Subjects on Ospemifene 15 mg/Day	29	28
Subjects on Ospemifene 30 mg/Day	30	27

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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percentage of parabasal cells

Measure	Subjects on Placebo n = 34	Subjects on Ospemifene 5 mg/Day n = 33	Subjects on Ospemifene 15 mg/Day n = 29	Subjects on Ospemifene 30 mg/Day n = 30
Value	-3.0 (30.2)	-2.8 (33.2)	-24.1 (36.7)	-26.8 (41.1)

Population analysed: ITT

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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percentage of superficial cells

Measure	Subjects on Placebo n = 34	Subjects on Ospemifene 5 mg/Day n = 33	Subjects on Ospemifene 15 mg/Day n = 29	Subjects on Ospemifene 30 mg/Day n = 30
Value	0.2 (1.5)	0.9 (3.1)	5.0 (9.1)	5.6 (10.3)

Population analysed: ITT

Primary outcome: Mean Change From Baseline in Vaginal pH

Time frame: 12 weeks. Mean (Standard Deviation). Unit: pH

Measure	Subjects on Placebo n = 34	Subjects on Ospemifene 5 mg/Day n = 33	Subjects on Ospemifene 15 mg/Day n = 29	Subjects on Ospemifene 30 mg/Day n = 30
Value	-0.07 (0.91)	-0.37 (0.83)	-0.95 (1.02)	-1.11 (1.06)

Population analysed: ITT

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects on Placebo	1 of 34 (2.9%)	25 of 34 (73.5%)	Not reported
Subjects on Ospemifene 5 mg/Day	0 of 33 (0%)	7 of 33 (21.2%)	Not reported
Subjects on Ospemifene 15 mg/Day	0 of 29 (0%)	13 of 29 (44.8%)	Not reported
Subjects on Ospemifene 30 mg/Day	0 of 30 (0%)	16 of 30 (53.3%)	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 2 study testing Ospemifene 5 mg, Ospemifene 15 mg and Ospemifene 30 mg 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 3 inclusion and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (time frame: 12 weeks). The study lists 3 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 NCT00630539.

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.