Tibolone Endometrium Study (Study 32972)(COMPLETED) - Full Text View

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 III

Drug Information available for:

Medroxyprogesterone Medroxyprogesterone 17-acetate Estrogens, conjugated Tibolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety Study

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

Further study details as provided by Organon:

Primary Outcome Measures:

Endometrial biopsy and histological examination [ Time Frame: At 1 year and 2 year. ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment:	32
Study Start Date:	October 2001
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tibolone 1.25 mg: Experimental	Drug: tibolone oral 1.25 mg tablet, once daily, for 2 years
Tibolone 2.5 mg: Experimental	Drug: Tibolone 2.5 mg oral 2.5 mg tablet, once daily, for 2 years
CE/MPA: Active Comparator	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

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders 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

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	32972
First Received:	September 2, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745108
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens, Conjugated (USP)

Tibolone

Medroxyprogesterone 17-Acetate

Medroxyprogesterone

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal

Contraceptive Agents

Antineoplastic Agents

Hormone Antagonists

Contraceptives, Oral

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female

Cardiovascular Agents

Reproductive Control Agents

Antihypertensive Agents

Contraceptive Agents, Male

Hormones

Pharmacologic Actions

Estrogen Receptor Modulators

Anabolic Agents

Androgen Antagonists

Therapeutic Uses

Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00745108