This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Tibolone Endometrium Study (Study 32972)(P06470) (THEBES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00745108
First received: September 2, 2008
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.

Condition Intervention Phase
Postmenopausal Women Drug: tibolone Drug: Tibolone 2.5 mg Drug: CE/MPA Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Endometrial biopsy and histological examination [ Time Frame: At 1 year and 2 year. ]

Secondary Outcome Measures:
  • Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log. [ Time Frame: TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording ]

Enrollment: 32
Actual Study Start Date: October 1, 2001
Study Completion Date: July 21, 2005
Primary Completion Date: July 21, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tibolone 1.25 mg Drug: tibolone
oral 1.25 mg tablet, once daily, for 2 years
Experimental: Tibolone 2.5 mg Drug: Tibolone 2.5 mg
oral 2.5 mg tablet, once daily, for 2 years
Other Name: Livial
Active Comparator: CE/MPA Drug: CE/MPA
oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years
Other Names:
  • Premarin
  • Provera

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

  • Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
  • Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS).
  • Any previous or current unopposed estrogen administration or tamoxifen citrate.
  • Any unexplained vaginal bleeding following the menopause.
  • Women with abnormal Pap smear test results (PAP IIb and higher)
  • Previous use of raloxifene hydrochloride for longer than one month.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00745108     History of Changes
Other Study ID Numbers: P06470
32972
Study First Received: September 2, 2008
Last Updated: April 6, 2017

Additional relevant MeSH terms:
Medroxyprogesterone
Medroxyprogesterone Acetate
Tibolone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antihypertensive Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones

ClinicalTrials.gov processed this record on September 21, 2017