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

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrial Hyperplasia; Endometrial Cancer

Intervention: progesterone (Drug); activella (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Boris Kaplan, prof, Principal Investigator, Affiliation: Rabin Medical Center Beilinson Hospital

Overall contact:
Aviva Kaplan, Phone: 972-3-9377534

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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.

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

Minimum age: 45 Years. Maximum age: 60 Years. Gender(s): Female.

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.

Locations and Contacts

Aviva Kaplan, Phone: 972-3-9377534

Rabin Medical Center Beilinson Hospital, Petach Tikva, Israel; Not yet recruiting
Aviva kaplan, Phone: 972-50-5511591
Boris kaplan, prof, Principal 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', Sub-Investigator
Additional Information

Related publications:

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

Starting date: June 2009
Last updated: June 11, 2009

Page last updated: August 23, 2015

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