Endometrial Cancer Clinical Trial
Official title:
Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | November 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center Beilinson Hospital | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center | Ferring Pharmaceuticals |
Israel,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. | 1 year | Yes | |
Secondary | Comparison of the proportion of bleeding pattern between the two groups. | 1 year | Yes | |
Secondary | To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. | 1 year | Yes |
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