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
|