Prescription event monitoring study to assess the safety profile of oral natural micronized progesterone sustained release in India

Purandare, AC; Hajare, Anoop L.; Krishnaprasad, Krupa; Bhargava, Anuja

doi:10.5958/2319-5886.2014.00034.4

Cited by 2 publications

(2 citation statements)

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“…The low incidence of adverse events associated with NMP-SR is further supported by a prescription-event monitoring study conducted in India. 39 The study evaluated 153 patients with a poor obstetric history (50%), unexplained fertility (43.8%) or secondary amenorrhea (5.9%) who received oral NMP-SR 300 or 400 mg once daily after natural or stimulated ART cycles. Oral NMP-SR was well tolerated.…”

Section: Reviewmentioning

confidence: 99%

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

Wagh¹,

Shankar²,

Bachani³

2021

DIC

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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.

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Section: Reviewmentioning

confidence: 99%

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

Wagh¹,

Shankar²,

Bachani³

2021

DIC

View full text Add to dashboard Cite

show abstract

“…38 The low incidence of adverse events associated with NMP-SR is further supported by a prescription-event monitoring study conducted in India. 39 The study evaluated 153 patients with a poor obstetric history (50%), unexplained fertility (43.8%) or secondary amenorrhea (5.9%) who received oral NMP-SR 300 or 400 mg once daily after natural or stimulated ART cycles. Oral NMP-SR was well tolerated.…”

Section: Safetymentioning

confidence: 99%

Conventional and sustained-release oral natural micronised progesterone in luteal phase support, threatened miscarriage, preterm birth, and high-risk pregnancy: a review

Wagh¹,

Kundavi

Bachani

2020

Preprint

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Exogenous progesterone is used to manage obstetric indications associated with reduced progesterone activity. This review examined evidence for oral natural micronised progesterone (NMP) and NMP-SR, a sustained-release formulation designed to overcome the limitations of conventional oral NMP. Oral NMP was effective for luteal phase support during assisted reproduction, and prevention of threatened spontaneous miscarriage and preterm delivery. NMP-SR was comparable to dydrogesterone for luteal phase support during assisted reproduction and maintenance of high-risk pregnancies. By releasing progesterone gradually and circumventing first-pass metabolism, NMP-SR elicits the desired therapeutic effect with added benefits of better bioavailability, once-daily dosing, and improved tolerability.

show abstract

Prescription event monitoring study to assess the safety profile of oral natural micronized progesterone sustained release in India

Cited by 2 publications

References 0 publications

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

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

Conventional and sustained-release oral natural micronised progesterone in luteal phase support, threatened miscarriage, preterm birth, and high-risk pregnancy: a review

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