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| ID | Type | Description | Link |
|---|---|---|---|
| 5340/09 |
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone vaginal tablet | Experimental | Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally. |
|
| Activella | Other | Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| progesterone | Drug | Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the proportion of bleeding pattern between the two groups. | 1 year | |
| To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aviva Kaplan | Contact | 972-3-9377534 |
| Name | Affiliation | Role |
|---|---|---|
| Boris Kaplan, prof | Rabin Medical Center Beilinson Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center Beilinson Hospital | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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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| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| C418365 | estradiol, norethindrone drug combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| activella | Drug | Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |