CompletedPhase 3

Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

631 participantsStarted 2016-01-26

Plain-language summary

The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.

Who can participate

Age range

40 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is postmenopausal. * Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA. Exclusion Criteria: * Subject has clinically significant abnormal findings in the physical examination. * Subject has a body mass index (BMI) equal to or greater than 38 kg/m\^2 * Subject has uncontrolled hypertension. * Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy. * Subject has uterine/vaginal bleeding of unknown origin. * Subject has a vaginal infection requiring medication (may be treated and be eligible for study).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12

Timeframe: Baseline and Week 12

Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12

Timeframe: Baseline and Week 12

Change From Baseline in the Vaginal pH at Week 12

Timeframe: Baseline and Week 12

Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12

Timeframe: Baseline and Week 12

Number of Participants With Adverse Events

Timeframe: From the first dose of study drug up to 14 days after the last dose; 14 weeks

Trial details

NCT IDNCT02638337

SponsorShionogi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-23

Results submitted2019-02-21

View on ClinicalTrials.gov More Vaginal Dryness trials

Who can participate

Age range

40 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12

Timeframe: Baseline and Week 12

Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12

Timeframe: Baseline and Week 12

Change From Baseline in the Vaginal pH at Week 12

Timeframe: Baseline and Week 12

Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12

Timeframe: Baseline and Week 12

Number of Participants With Adverse Events

Timeframe: From the first dose of study drug up to 14 days after the last dose; 14 weeks