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AtrophyPhase 3NCT01586364

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

A Phase 3 study testing Ospemifene 60Mg Oral Tablet 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.

Official record
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Trial summary

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a 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 60Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
No sites listed yet
Study dates
8 May 2006to 22 Dec 2008
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

  • Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
  • Did not have a uterus
  • Met the inclusion and exclusion criteria for Protocol 15-50310
  • Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310
  • Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits

Who cannot join

  • Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
  • Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

About this study

Official title: Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus: A 52-Week Open-Label Follow-Up to Protocol 15-50310

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

Being tested
Ospemifene 60Mg Oral Tablet
Keywords
Menopausal symptoms, Vulvar and vaginal atrophy in menopausal women, 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 60Mg Oral TabletDrug

    Also called Osphena®

Study groups in NCT01586364
Study groupRoleWhat they receive
Ospemifene 60 mg Oral TabletExperimentalParticipants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
Receives: Drug: Ospemifene 60Mg Oral Tablet

What is being measured

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

  1. Incidence of Adverse Events (AEs)

    Measured: Week 13 (Phone Contact) to Week 56 (Visit 4)

  2. Change From Baseline in Serum Lipid Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  3. Change From Baseline in Serum Lipid Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  4. Change From Baseline in Blood Pressure at Visit 2

    Systolic blood pressure (SBP), diastolic blood pressure (DBP)

    Measured: Baseline to Week 26 (Visit 2)

  5. Change From Baseline in Pulse Rate at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  6. Change From Baseline in Weight at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  7. Change From Baseline in Body Mass Index (BMI) at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  8. Change From Baseline in Blood Pressure at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  9. Change From Baseline in Pulse Rate at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  10. Change From Baseline in Weight at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  11. Change From Baseline in BMI at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  12. Change From Baseline in Visual Evaluation of Vagina at Visit 2

    Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

    Measured: Baseline to Week 26 (Visit 2)

  13. Change From Baseline in Visual Evaluation of Vagina at Visit 3

    Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

    Measured: Baseline to Week 52 (Visit 3)

  14. Assessment of Cervical Pap Smear Samples (if Cervix is Intact)

    Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.

    Measured: Week 52 (Visit 3)

  15. Assessment of Breast Palpation at Visit 2

    Breast palpation was used to assess breast abnormalities.

    Measured: Week 26 (Visit 2)

  16. Assessment of Breast Palpation at Visit 3

    Breast palpation was used to assess breast abnormalities.

    Measured: Week 52 (Visit 3)

  17. Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  18. Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  19. Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  20. Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  21. Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  22. Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  23. Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  24. Change From Baseline in Erythrocyte Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  25. Change From Baseline in Hemoglobin Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  26. Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  27. Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  28. Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  29. Change From Baseline in Erythrocyte Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  30. Change From Baseline in Hemoglobin Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  31. Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  32. Change From Baseline in MCV and MPV at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  33. Change From Baseline in Albumin and Total Protein Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  34. Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  35. Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  36. Change From Baseline in Albumin and Total Protein Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  37. Change From Baseline in ALT, AST and CK Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  38. Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  39. Change From Baseline in pH of Urine at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  40. Change From Baseline in Specific Gravity of Urine at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  41. Change From Baseline in pH of Urine at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  42. Change From Baseline in Specific Gravity of Urine at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  43. Change From Baseline in Estradiol (E2) Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  44. Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  45. Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  46. Change From Baseline in Testosterone Levels at Visit 2

    Measured: Baseline to Week 26 (Visit 2)

  47. Change From Baseline in E2 Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  48. Change From Baseline in FSH and LH Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  49. Change From Baseline in SHBG Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

  50. Change From Baseline in Testosterone Levels at Visit 3

    Measured: Baseline to Week 52 (Visit 3)

Timeline

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

  1. First posted26 Apr 2012 (estimated)
  2. Study start8 May 2006
  3. Primary completion21 Nov 2008
  4. Study completion22 Dec 2008

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586364
Sponsor's protocol ID
15-50312
Status last verified
Apr 2018
First submitted
18 Apr 2012
Last updated
21 May 2018
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ospemifene 60Mg Oral Tablet 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 2 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 21 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. 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?

Incidence of Adverse Events (AEs) (time frame: Week 13 (Phone Contact) to Week 56 (Visit 4)). The study lists 50 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 NCT01586364.

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 21 May 2018.

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