Study Comparing 17B Estradiol/TMG CC 1mg vs. Tibolone in Postmenopausal Women - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00472004

Purpose

This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).

Condition	Intervention	Phase
Vasomotor Symptoms	Drug: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined Drug: Tibolone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomised, Open Label Study to Compare the Efficacy, Safety and Tolerability of 17B Estradiol/TMG CC 1mg and Tibolone in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate Tibolone

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Evaluate the efficacy of Totelle and Tibolone in controlling the vasomotor symptoms and cycle control [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the effects of Totelle and Tibolone on tolerability profile defined as: weight changes, breast tenderness; Quality of Life and Adherence to Treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration	Drug: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
2: Active Comparator Tibolone 2.5 mg 1 daily, 1 year duration	Drug: Tibolone Tibolone 2.5 mg 1 daily, 1 year duration

Eligibility

Ages Eligible for Study:	45 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Generally healthy postmenopausal women
Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
At least 1 year of natural occurring amenorrhea

Exclusion Criteria

Known or suspected estrogen-dependent neoplasia
Endometrial hyperplasia
Any malignancy with the exception of a history of basal cell carcinoma of the skin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472004

Locations

Mexico

Puebla, Mexico, 72410
Mexico, DF

Mexico, DF, Mexico, 6700

Mexico, DF, Mexico, 53100

Mexico, DF, Mexico, 11000

Mexico, DF, Mexico, 11800
Mexico, Nuevo Leon

Monterrey, Nuevo Leon, Mexico, 64060

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0753T-101800
Study First Received:	May 8, 2007
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00472004 History of Changes
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:

Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Estradiol 17 beta-cypionate
Reproductive Control Agents

Antihypertensive Agents
Hormones
Estradiol
Pharmacologic Actions
Estrogen Receptor Modulators
Anabolic Agents
Androgen Antagonists
Tibolone
Therapeutic Uses
Estradiol 3-benzoate
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 09, 2009