A review of conventional and sustained-release formulations of oral natural micronized progesterone in obstetric indications

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Background: Exogenous progesterone is a treatment option for obstetric indications associated with reduced progesterone activity. Oral natural micronized progesterone (NMP) is effective, although it requires multiple daily doses and may cause adverse events due to its active metabolites. A sustained-release formulation of NMP (NMP-SR) has been developed to overcome the limitations of conventional oral NMP.

Methods: This narrative review examines the available evidence for oral NMP and NMP-SR in several obstetric indications of interest.

Results: Literature searches identified 17 studies of oral NMP (luteal phase support during assisted reproduction, prevention of threatened miscarriage, prevention of preterm delivery), and clinical studies supporting use of NMP-SR (luteal phase support during intrauterine insemination, maintenance of high-risk pregnancy). Oral NMP was effective for luteal phase support during in vitro fertilization and intrauterine insemination, prevention of threatened miscarriage, and prevention of preterm delivery. NMP-SR was comparable to dydrogesterone for luteal phase support during intrauterine insemination and effectively maintained high-risk pregnancies. Oral NMP-SR was well tolerated.

Conclusions: By releasing progesterone gradually and circumventing first-pass metabolism, NMP-SR elicits the desired therapeutic effect with benefits over conventional oral NMP in terms of bioavailability, once-daily dosing and improved tolerability. Oral NMP-SR appears to be a valuable option for treating obstetric conditions associated with insufficient progesterone exposure.

Keywords: high-risk pregnancy, luteal support, natural micronized progesterone, preterm labour, sustained-release formulations, threatened miscarriage.

Citation: Wagh GN, Kundavi Shankar KM, Bachani S. A review of conventional and sustained-release formulations of oral natural micronized progesterone in obstetric indications. Drugs Context. 2021;10:2021-7-1. https://doi.org/10.7573/dic.2021-7-1

Contributions: The authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: No potential conflicts of interest were declared by the authors. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2021/09/dic.2021-7-1-COI.pdf

Acknowledgements: Medical writing and editing support during preparation of this manuscript was provided by Kathy Croom and Kerry Dechant on behalf of Content Ed Net (Mumbai, India), with funding from Sun Pharma (Mumbai, India). This manuscript is a review article and does not involve a research protocol requiring approval by a relevant institutional review board or ethics committee.

Funding declaration: Writing assistance was funded by Sun Pharma (Mumbai, India).

Copyright: Copyright © 2021 Wagh GN, Kundavi Shankar KM, Bachani S. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2021 Wagh GN, Kundavi Shankar KM, Bachani S. https://doi.org/10.7573/dic.2021-7-1. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://drugsincontext.com/a-review-of-conventional-and-sustained-release-formulations-of-oral-natural-micronized-progesterone-in-obstetric-indications

Correspondence: Girija Narendrakumar Wagh, Girija Hospital & Fertility Centre, Sr. no 87, Azad Nagar, Near Sutar Dawakhana, Kothrud, Pune, 411029, Maharashtra State, India. Email: girijawagh@gmail.com

Provenance: Submitted; externally peer reviewed.

Submitted: 2 July 2021; Accepted: 24 August 2021; Publication date: 13 October 2021.

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