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

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Shionogi

Status and phase

Completed
Phase 3

Conditions

Vaginal Dryness

Treatments

Drug: Ospemifene
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02638337
1517I0231

Details and patient eligibility

About

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.

Enrollment

631 patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

631 participants in 2 patient groups, including a placebo group

Ospemifene
Experimental group
Description:
Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
Treatment:
Drug: Ospemifene
Placebo
Placebo Comparator group
Description:
Participants will take one tablet of matching placebo, orally, once a day for 12 weeks.
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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