NCT00165204

Brief Summary

Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

Enrollment Period

1.9 years

First QC Date

September 9, 2005

Last Update Submit

December 20, 2007

Conditions

MenopausePostmenopausal Bone LossBreast Cancer

Keywords

TiboloneHigh risk womenOophorectomyBreast DensityBone Density

Outcome Measures

Primary Outcomes (1)

  • To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo

Secondary Outcomes (1)

  • To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo

Interventions

TiboloneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good overall health
  • Premenopausal at the time of enrollment if before their oophorectomy
  • Will undergo or have undergone an oophorectomy
  • Negative breast examination and negative breast imaging studies

You may not qualify if:

  • History of breast cancer, ductal carcinoma in situ (DCIS) or other cancer except for carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • History of ovarian cancer, breast cancer (or DCIS) or other malignancy
  • Low bone mass compared with age-adjusted controls
  • Current or recent exposure (within 3 months) to medications that alter bone metabolism
  • Estrogens, progesterones, androgens, tamoxifen or raloxifene within 3 months of randomization
  • History of significant medical problems potentially related to estrogens
  • History of Paget's disease of bone, ankylosing spondylitis, rheumatoid arthritis or other metabolic bone disease, vitamin D deficiency, hyperparathyroidism, or newly diagnosed hyperthyroidism
  • Body mass index (BMI) \> 32
  • High-density lipoprotein (HDL) cholesterol \< 40 mg/dl
  • Women whose uterus was retained and who have a history of uterine abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • McCauley LS, Ghatas MP, Sumrell RM, Cirnigliaro CM, Kirshblum SC, Bauman WA, Gorgey AS. Measurement of Visceral Adipose Tissue in Persons With Spinal Cord Injury by Magnetic Resonance Imaging and Dual X-Ray Absorptiometry: Generation and Application of a Predictive Equation. J Clin Densitom. 2020 Jan-Mar;23(1):63-72. doi: 10.1016/j.jocd.2018.12.003. Epub 2018 Dec 15.

    PMID: 30638769DERIVED

MeSH Terms

Conditions

Osteoporosis, PostmenopausalBreast Neoplasms

Interventions

tibolone

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Judy Garber, MD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

April 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(3)