AtrophyPhase 3NCT00729469

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

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 safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity. 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: 919 participants
Where: No sites listed yet
Study dates: Jul 2008to Aug 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
Moderate or severe symptoms of vaginal atrophy
5% or fewer superficial cells in maturation index of vaginal smear
Vaginal pH greater than 5.0
Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Who cannot join

Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
Current vaginal infection requiring medication
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.
uterine or vaginal prolapse of Grade 2 or higher)
Previous participation in any other ospemifene study

About this study

Official title: Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women

Conditions: Atrophy, Vaginal Diseases
Being tested: Ospemifene 60 mg, Placebo
Keywords: Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms, Vaginal atrophy, Urogenital 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 oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
PlaceboDrug
oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Study groups in NCT00729469
Study group	Role	What they receive
Ospemifene 60 mg/day and K-Y® lubricant	Experimental	Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. Receives: Drug: Ospemifene 60 mg
Placebo and K-Y® lubricant	Placebo comparator	Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)
Measured: 12 weeks
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
Measured: 12 weeks

Secondary outcomes (8)

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)
Measured: 4 weeks
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)
Measured: 4 weeks

Timeline

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

Jul 2008Aug 2009

First posted7 Aug 2008 (estimated)
Study startJul 2008
Primary completionAug 2009
Study completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
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, Care provider, Investigator
Enrolment: 919 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00729469
Sponsor's protocol ID: 15-50821
Status last verified: Apr 2018
First submitted: 4 Aug 2008
Last updated: 18 May 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.
PubMed 23361170

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 Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women
ClinicalTrials.gov ID: NCT00729469
Acronym / sponsor ID: 15-50821
Conditions: Atrophy, Vaginal Diseases
Keywords: Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms, Vaginal atrophy, Urogenital atrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 919 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Collaborators: Hormos Medical, QuatRx Pharmaceuticals
Study start: Jul 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 7 Aug 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, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Ospemifene 60 mg/day and K-Y® lubricant	Experimental	Drug: Ospemifene 60 mgSubjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
Placebo and K-Y® lubricant	Placebo comparator	Drug: PlaceboSubjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Who may qualify

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

Key inclusion criteria (5 listed)

Naturally or surgically menopausal
Moderate or severe symptoms of vaginal atrophy
5% or fewer superficial cells in maturation index of vaginal smear
Vaginal pH greater than 5.0
Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Key exclusion criteria (5 listed)

Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
Current vaginal infection requiring medication
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.
uterine or vaginal prolapse of Grade 2 or higher)
Previous participation in any other ospemifene study

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 oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed	Drug	Ospemifene 60 mg/day and K-Y® lubricant
Placebooral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed	Drug	Placebo and K-Y® lubricant

Primary outcome

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)
Time frame: 12 weeks
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
Time frame: 12 weeks

8 secondary outcomes

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)
Time frame: 4 weeks
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)
Time frame: 4 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	456	403
Subjects on Ospemifene 60 mg/Day	463	416

Primary outcome: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)

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

Measure	Subjects on Placebo n = 154	Subjects on Ospemifene 60 mg/Day n = 160
Value	-3.7 (29.97)	-31.7 (37.25)

Population analysed: ITT; LOCF

Primary outcome: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)

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

Measure	Subjects on Placebo n = 154	Subjects on Ospemifene 60 mg/Day n = 160
Value	3.3 (9.02)	12.4 (15.36)

Population analysed: ITT; LOCF

Primary outcome: Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)

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

Measure	Subjects on Placebo n = 154	Subjects on Ospemifene 60 mg/Day n = 160
Value	-0.24 (0.800)	-0.92 (1.100)

Population analysed: ITT; LOCF

Primary outcome: Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

Time frame: 12 weeks. Number. Unit: participants

Measure	Subjects on Placebo n = 154	Subjects on Ospemifene 60 mg/Day n = 160
-3 (Sev. to none)	14	23
-2 (Sev. to mild, or mod. to none)	39	51
-1 (Sev. to mod., mod.to mild, or mild to none)	52	39
0 (No change)	44	44
1 (None to mild, mild to mod., or mod. to sev.)	5	3

Population analysed: ITT; LOCF

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects on Placebo	7 of 456 (1.5%)	102 of 456 (22.4%)	Not reported
Subjects on Ospemifene 60 mg/Day	6 of 463 (1.3%)	153 of 463 (33%)	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.
Derived from this study: PubMed 23361170Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.

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A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
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A Study of Bimagrumab in Participants With HFpEF
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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.

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 5 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 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?

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) (time frame: 12 weeks). The study lists 8 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 NCT00729469, which also lists 1 linked publication.

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.