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CompletedNCT00310531Updated Dec 30, 2014

3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

A Phase 3 interventional study of Menostar (Estradiol, BAY86-5435) and Raloxifene in Osteopenia, sponsored by Bayer. Completed. Open to female participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Bayer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
Female
01

Study summary

The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.

Read the detailed description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

02

Conditions studied

  • Osteopenia
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 500 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Last (regular) menstrual period more than 5 years ago
  • Relative good state of health
  • Intact, normal uterus

Exclusion criteria

Exclusion Criteria:

  • Bone and musculoskeletal diseases
  • Clinically significant vertebral fracture within the last 12 months
  • Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
  • Uncontrolled diabetes mellitus (or treated with insulin)
  • Uncontrolled thyroid disorders
  • Relevant renal disorder or significant liver dysfunction (including cholestasis)
  • History of alcohol or drug abuse
  • History of immobilization of more than 2 months in the last 6 months
  • Smoking of more than 10 cigarettes per day
  • Unexplained uterine bleeding
  • Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Menostar (Estradiol, BAY86-5435)

  • Active comparator
    Arm 2

    Drug: Raloxifene

Interventions

  • DrugMenostar (Estradiol, BAY86-5435)

    Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

  • DrugRaloxifene

    Raloxifene tbl. (60 mg/day)

06

What researchers measure

Primary outcomes

  1. Percentage change in Bone Mineral Density at the lumbar spine

    Time frame: after 3 years

Secondary outcomes

  1. Percentage change in Bone Mineral Density of the hip

    Time frame: after 3 years

  2. Percentage change in biochemical markers of bone turnover

    Time frame: after 6 months

  3. Proportion of patients with hot flushes

    Time frame: after 3 year

  4. Change in Women's Health Questionnaire

    Time frame: after 2 years

  5. Proportion of patients with an abnormal endometrial biopsy

    Time frame: after 3 years

  6. Pharmacogenetic analysis

    Time frame: after 2 years

  7. Digital breast density analysis

    Time frame: after 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00310531
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Apr 4, 2006
Start date
Feb 2004
Completion
Jun 2007
Last update
Dec 30, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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