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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by Rabin Medical Center. Recruitment status was Not yet recruiting

First Received on June 9, 2009. Last Updated on June 11, 2009 History of Changes

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Norethindrone acetate Progesterone Norethindrone

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
Experimental: Progesterone vaginal tablet 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 Other Name: Endometrin
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	Not yet recruiting
Petach Tikva, Israel
Contact: Aviva kaplan 972-50-5511591
Principal Investigator: Boris kaplan, prof
Sub-Investigator: Michael Hirsh, Dr'
Sub-Investigator: Ravit Nahum, Dr'
Sub-Investigator: Dove Lazarovitz, Dr'
Sub-Investigator: Avi Ninio, Dr'
Sub-Investigator: Yosi Maai, Dr'
Sub-Investigator: Dan Kelman, Dr'
Sub-Investigator: Raia Nir, Dr'
Sub-Investigator: Ruth Bloch, Dr'
Sub-Investigator: Yehuda Yeger, Dr'
Sub-Investigator: Reuven Amster, Dr'
Sub-Investigator: Tzvi Zehavi, Dr'
Sub-Investigator: Gay Gutman, Dr'
Sub-Investigator: Yosi Menkas, Dr'

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

Keywords provided by Rabin Medical Center:

menopause
Endometrial Thickness
progesterone

Additional relevant MeSH terms:

Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Estrogens
Norethindrone acetate

Norethindrone
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Progestins

ClinicalTrials.gov processed this record on February 09, 2012