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Oral micronized progesterone
1Department of Endocrinology and Reproductive Medicine, Hôpital Necker, Paris, France.
Clinical Therapeutics
|March 25, 1999
Summary
Oral micronized progesterone is a safer alternative to synthetic progestins for endometrial protection during estrogen therapy. It offers comparable bioavailability and efficacy with fewer metabolic and vascular side effects.
Area of Science:
- Endocrinology
- Pharmacology
- Gynecology
Background:
- Unopposed estrogen therapy increases risks of endometrial hyperplasia and adenocarcinoma.
- Synthetic progestins like norethisterone and medroxyprogesterone acetate have associated metabolic and vascular side effects.
- Natural progesterone is biologically identical to endogenous hormones.
Purpose of the Study:
- To review the rationale for using oral micronized progesterone over synthetic progestins for key indications.
- To evaluate the safety and efficacy of oral micronized progesterone in endometrial protection.
- To compare oral micronized progesterone with synthetic progestins in managing estrogen therapy side effects.
Main Methods:
- Review of comparative studies and clinical trial data.
- Analysis of pharmacokinetic data, including bioavailability and variability.
- Examination of endometrial protection and side effect profiles.
Main Results:
- Oral micronized progesterone demonstrates comparable bioavailability and inter/intra-individual variability to synthetic progestins.
- It provides effective long-term endometrial protection with a favorable side effect profile, mainly mild drowsiness.
- Comparative studies indicate synthetic progestins' side effects are minimized or eliminated with natural progesterone.
Conclusions:
- Oral micronized progesterone is recommended as a preferred option for opposing estrogen therapy in nonhysterectomized postmenopausal women.
- It offers a safer alternative to synthetic progestins, mitigating risks of endometrial hyperplasia and adenocarcinoma.
- The oral formulation circumvents inconvenience, providing a well-tolerated and effective therapeutic option.