Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen - Full Text View

Sponsor:	Rabin Medical Center
Collaborator:	Ferring Pharmaceuticals
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00919919

Purpose

The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.

Condition	Intervention	Phase
Endometrial Hyperplasia Endometrial Cancer	Drug: progesterone Drug: activella	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Menopause

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Comparison of the proportion of bleeding pattern between the two groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Progesterone vaginal tablet: Experimental Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.	Drug: progesterone Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
Activella Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally	Drug: activella Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Detailed Description:

Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.

Eligibility

Ages Eligible for Study:	45 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
Women with an intact uterus.
No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
Endometrial thickness ≤ 5 mm.

Exclusion Criteria:

Submucosal fibroid/s that applying pressure and affecting endometrial thickness
Other medication that could affect estrogenic state.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919919

Contacts

Contact: Aviva Kaplan

972-3-9377534

Locations

Israel
Rabin Medical Center Beilinson Hospital
Petach Tikva, Israel

Sponsors and Collaborators

Rabin Medical Center

Ferring Pharmaceuticals

Investigators

Principal Investigator:

Boris Kaplan, prof

Rabin Medical Center Beilinson Hospital

More Information

No publications provided

Responsible Party:	Gynecology Department ( Prof. Boris Kaplan )
Study ID Numbers:	fr003, 5340/09
Study First Received:	June 9, 2009
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00919919 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

menopause
Endometrial Thickness
progesterone

Additional relevant MeSH terms:

Estrogens
Progesterone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Hormones
Pharmacologic Actions

Genital Diseases, Female
Hyperplasia
Endometrial Neoplasms
Neoplasms
Pathologic Processes
Neoplasms by Site
Progestins
Uterine Neoplasms
Endometrial Hyperplasia

ClinicalTrials.gov processed this record on February 04, 2010