AtrophyPhase 3NCT00566982

A Clinical Study to Evaluate the Safety of Ospemifene

A Phase 3 study testing Ospemifene 60 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.

Trial summary

The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus. 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 60 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 426 participants
Where: No sites listed yet
Study dates: Oct 2007to Jul 2009
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 menopausal
Intact uterus
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 Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

Conditions: Atrophy, Vaginal Diseases
Being tested: Ospemifene 60 mg, Placebo
Keywords: Urogenital atrophy, Menopausal symptoms, 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.

Ospemifene 60 mgDrug
Also called Osphena®
60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
PlaceboDrug
Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Study groups in NCT00566982
Study group	Role	What they receive
Ospemifene 60 mg/day	Experimental	Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. Receives: Drug: Ospemifene 60 mg
Placebo	Placebo comparator	Placebo will be taken once daily, in the morning, with food for 52 weeks. Receives: Drug: Placebo

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

Secondary outcomes (5)

Change From Baseline in Estradiol Levels
Measured: 52 weeks
Change From Baseline in Luteinizing Hormone Levels
Measured: 52 weeks
Change From Baseline in Follicle Stimulating Hormone Levels
Measured: 52 weeks
Change From Baseline in Sex Hormone Binding Globulin Levels
Measured: 52 weeks
Visual Evaluation of the Vagina (Baseline & Week 52)
Measured: 52 weeks

Timeline

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

Oct 2007Jul 2009

First posted4 Dec 2007 (estimated)
Study startOct 2007
Primary completionJul 2009
Study completionJul 2009

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00566982
Sponsor's protocol ID: 15-50718
Status last verified: Apr 2018
First submitted: 30 Nov 2007
Last updated: 18 May 2018
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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All Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo
ClinicalTrials.gov ID: NCT00566982
Acronym / sponsor ID: 15-50718
Conditions: Atrophy, Vaginal Diseases
Keywords: Urogenital atrophy, Menopausal symptoms, Vulvar and vaginal atrophy in postmenopausal women, Vaginal atrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Collaborators: Hormos Medical, QuatRx Pharmaceuticals
Study start: Oct 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 4 Dec 2007 (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 the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ospemifene 60 mg/day	Experimental	Drug: Ospemifene 60 mgOspemifene will be taken orally, once daily, in the morning, with food for 52 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo will be taken once daily, in the morning, with food for 52 weeks.

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 menopausal
Intact uterus
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
Ospemifene 60 mgAlso: Osphena®60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.	Drug	Ospemifene 60 mg/day
PlaceboDosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)	Drug	Placebo

Primary outcome

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

5 secondary outcomes

Change From Baseline in Estradiol Levels
Time frame: 52 weeks
Change From Baseline in Luteinizing Hormone Levels
Time frame: 52 weeks
Change From Baseline in Follicle Stimulating Hormone Levels
Time frame: 52 weeks
Change From Baseline in Sex Hormone Binding Globulin Levels
Time frame: 52 weeks
Visual Evaluation of the Vagina (Baseline & Week 52)
Time frame: 52 weeks

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 (Baseline)	63	55
Subjects on Ospemifene 60 mg/Day (Baseline)	363	294

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

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

Measure	Subjects on Placebo (Baseline) n = 63	Subjects on Ospemifene 60 mg/Day (Baseline) n = 363
Value	5.0 (27.86)	-46.0 (41.96)

Population analysed: ITT

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

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

Measure	Subjects on Placebo (Baseline) n = 63	Subjects on Ospemifene 60 mg/Day (Baseline) n = 363
Value	1.0 (4.36)	10.3 (12.53)

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 (Baseline) n = 63	Subjects on Ospemifene 60 mg/Day (Baseline) n = 363
Value	-0.16 (0.945)	-1.21 (0.912)

Population analysed: ITT

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 Weeks; From the signing of the informed consent form to the last safety evaluation (Week 12). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects on Placebo (Baseline)	4 of 62 (6.5%)	37 of 62 (59.7%)	Not reported
Subjects on Ospemifene 60 mg/Day (Baseline)	18 of 364 (4.9%)	252 of 364 (69.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrophy

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
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Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ospemifene 60 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 4 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 18 May 2018. 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 Percentage of Parabasal Cells in Maturation Index of 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 NCT00566982.

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 18 May 2018.