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

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ClinicalTrials.gov Identifier: NCT02638337
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Brief 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.

Condition or disease Intervention/treatment Phase
Vaginal Dryness Drug: Ospemifene Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebocontrolled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause
Actual Study Start Date : January 26, 2016
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Ospemifene

Arm Intervention/treatment
Experimental: Ospemifene
Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
Drug: Ospemifene
60 mg tablet

Placebo Comparator: Placebo
Participants will take one tablet of matching placebo, orally, once a day for 12 weeks.
Drug: Placebo
Tablet identical to the ospemifene tablet without drug




Primary Outcome Measures :
  1. Change from baseline in the percentage of parabasal cells in the maturation index of the vaginal smear [ Time Frame: Baseline and Week 12 ]
    Histological laboratory evaluation

  2. Change from baseline in the percentage of superficial cells in the maturation index of the vaginal smear [ Time Frame: Baseline and Week 12 ]
    Histological laboratory evaluation

  3. Change from baseline in the vaginal pH [ Time Frame: Baseline and Week 12 ]
    pH test strip

  4. Change from baseline in the severity of self-reported most bothersome symptom (MBS) of vaginal dryness [ Time Frame: Baseline and Week 12 ]
    Questionnaire

  5. The number of adverse events [ Time Frame: Baseline to end of study ]
    The incidence of AEs in patients after ospemifene and after placebo


Secondary Outcome Measures :
  1. Change from baseline in the percentage of parabasal cells in the maturation index of the vaginal smear [ Time Frame: Baseline and weeks 4 and 8 ]
  2. Change from baseline in the percentage of superficial cells in the maturation index of the vaginal smear [ Time Frame: Baseline and weeks 4 and 8 ]
  3. Change from baseline in the vaginal pH [ Time Frame: Baseline and weeks 4 and 8 ]
  4. Change from baseline in the severity of self-reported most bothersome symptom (MBS) of vaginal dryness [ Time Frame: Baseline and weeks 4 and 8 ]
  5. Change from baseline in the severity of other VVA symptoms different from vaginal dryness [ Time Frame: Baseline and Week 12 ]
    Questionnaire for symptoms of VVA

  6. Change from baseline in markers of bone metabolism [ Time Frame: Baseline and Week 12 ]
    Blood and urinary bone metabolic markers will be measured

  7. Change from baseline in Vaginal Health Index (VHI) [ Time Frame: Baseline and Week 12 ]
    The Investigator will perform an evaluation of the vagina

  8. Change from baseline in Vulvar Health Index (VuHI) [ Time Frame: Baseline and Week 12 ]
    the Investigator will perform a visual examination of the vulva

  9. Change from baseline in Female Sexual Function Index (FSFI) [ Time Frame: Baseline and Week 12 ]
    Questionnaire

  10. Change from baseline in Urogenital Distress Inventory (UDI)-6 [ Time Frame: Baseline and Week 12 ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638337


  Show 83 Study Locations
Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi

Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT02638337     History of Changes
Other Study ID Numbers: 1517I0231
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Keywords provided by Shionogi Inc. ( Shionogi ):
Vulvo-vaginal Atrophy
menopause

Additional relevant MeSH terms:
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents