Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
NCT ID: NCT00919919
Last Updated: 2009-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2009-06-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Progesterone vaginal tablet
Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.
progesterone
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
Activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Interventions
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progesterone
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Other medication that could affect estrogenic state.
45 Years
60 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Rabin Medical Center
OTHER
Responsible Party
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Gynecology Department
Principal Investigators
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Boris Kaplan, prof
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center Beilinson Hospital
Locations
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Rabin Medical Center Beilinson Hospital
Petah Tikva, , Israel
Countries
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Central Contacts
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Aviva Kaplan
Role: CONTACT
Facility Contacts
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Aviva kaplan
Role: primary
References
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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
Other Identifiers
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5340/09
Identifier Type: -
Identifier Source: secondary_id
fr003
Identifier Type: -
Identifier Source: org_study_id
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