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

Primary Purpose

Endometrial Hyperplasia, Endometrial Cancer

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

progesterone

activella

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring menopause, Endometrial Thickness, progesterone

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Rabin Medical Center Beilinson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Progesterone vaginal tablet

Activella

Arm Description

Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.

Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Outcomes

Primary Outcome Measures

Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.

Secondary Outcome Measures

Comparison of the proportion of bleeding pattern between the two groups.

To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.

Full Information

NCT ID

NCT00919919

First Posted

June 9, 2009

Last Updated

June 11, 2009

Sponsor

Rabin Medical Center

Collaborators

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00919919

Brief Title

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

Official Title

Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Rabin Medical Center

Collaborators

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Hyperplasia, Endometrial Cancer

Keywords

menopause, Endometrial Thickness, progesterone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Progesterone vaginal tablet

Arm Type

Experimental

Arm Description

Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.

Arm Title

Activella

Arm Type

Other

Arm Description

Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Intervention Type

Drug

Intervention Name(s)

progesterone

Other Intervention Name(s)

Endometrin

Intervention Description

Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month

Intervention Type

Drug

Intervention Name(s)

activella

Intervention Description

Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Primary Outcome Measure Information:

Title

Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Comparison of the proportion of bleeding pattern between the two groups.

Time Frame

1 year

Title

To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aviva Kaplan

Phone

972-3-9377534

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris Kaplan, prof

Organizational Affiliation

Rabin Medical Center Beilinson Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center Beilinson Hospital

City

Petach Tikva

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aviva kaplan

Phone

972-50-5511591

First Name & Middle Initial & Last Name & Degree

Boris kaplan, prof

First Name & Middle Initial & Last Name & Degree

Michael Hirsh, Dr'

First Name & Middle Initial & Last Name & Degree

Ravit Nahum, Dr'

First Name & Middle Initial & Last Name & Degree

Dove Lazarovitz, Dr'

First Name & Middle Initial & Last Name & Degree

Avi Ninio, Dr'

First Name & Middle Initial & Last Name & Degree

Yosi Maai, Dr'

First Name & Middle Initial & Last Name & Degree

Dan Kelman, Dr'

First Name & Middle Initial & Last Name & Degree

Raia Nir, Dr'

First Name & Middle Initial & Last Name & Degree

Ruth Bloch, Dr'

First Name & Middle Initial & Last Name & Degree

Yehuda Yeger, Dr'

First Name & Middle Initial & Last Name & Degree

Reuven Amster, Dr'

First Name & Middle Initial & Last Name & Degree

Tzvi Zehavi, Dr'

First Name & Middle Initial & Last Name & Degree

Gay Gutman, Dr'

First Name & Middle Initial & Last Name & Degree

Yosi Menkas, Dr'

12. IPD Sharing Statement

Citations:

Citation

1. Jennifer Blake. Menopause: evidence-based practice. Best Practice & Research Clinical Obstetrics and Gynaecology. 2006;20:799-839 2. Deborah Graby: Management of Menopausal Symptoms. The NEW ENGLAND JOURNAL of MEDICINE. 2006; 355:2338-47 3. Elena M. Treatment Strategies for Reducing the Burden of Menopause-Associated Vasomotor Symptoms. Journal of Managed Care Pharmacy. 2008;14(3):s14-s19 4. T.Levy. Z.Ben-Refael et al. Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet. Human Reproduction. 1999;14(3):606-10 6. Devroey P, Palermo G, Bourgain C, et al. Progesterone administration in patients with absent ovaries. Int J Fertile. 1989;34:188- 93 7. Maxson WS, Hargrove JT. Bioavailability of oral micronized progesterone. Fertile Steril. 1985;44:622-26 8. C.Ficicioglu, B. Gurbuz, H. Canova. High local endometrial effect of vaginal progesterone gel. Gynecol Endocrinol. 2004;18:240-43 9. Steege JF, Rupp SL, Stout AL, et al. Bioavailability of nasally administered progesterone. Fertile Steril. 1986;46:722-29 10. Chakmakjian ZH, Zachariah NY. Bioavailability of progesterone with different modes of administration. J Reprod Med. 1987;32:443-48

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

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