Evidence map›Paper›PMID 39584456›Full record

ArticleXenobiotica; the fate of foreign compounds in biological systems2024

Vaginal administration of 17-alpha hydroxyprogesterone caproate appears to be safe in non-pregnant female rats and rabbits.

Imam H Shaik, Nupur Chaphekar, Vignesh Vasudevan, Ali Alshabi, Athbah AlOwaifeer, Wenchen Zhao, Steve Caritis, Raman Venkataramanan

Abstract read
In one paragraph

Article in Xenobiotica; the fate of foreign compounds in biological systems, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Imam H ShaikDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Nupur ChaphekarDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Vignesh VasudevanDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Ali AlshabiDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Athbah AlOwaifeerDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Wenchen ZhaoDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Steve CaritisDepartment of Obstetrics, Gynaecology and Reproductive Sciences, School of Medicine, Magee-Women's Hospital, Pittsburgh, Pennsylvania, USA.
Raman VenkataramananDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Funding

Pregnancy and Drug Metabolizing Enzymes and TransportersU10HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2004 to 2014
$9.7M
Optimization of Drug Dosing in Pregnant Women through Research and EducationU54HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2015 to 2019
$3.7M
NICHD NIH HHS U10 HD047905NICHD NIH HHS U54 HD047905
6 · The paper itself

Abstract

Intramuscular (250 mg once weekly) or subcutaneous (275 mg once weekly) injections of 17-hydroxyprogesterone caproate (17-OHPC) has been utilised to prevent recurent spontaneous preterm birth in pregnant women with a short cervix or those with a prior preterm birth but its efficacy in these conditions has been questioned. It is unclear whether adequate concentrations of 17-OHPC reach the suspected target organs such as the cervix and uterus following either IM or SC administration.The objective of this study was to determine feasibility and safety of vaginal administration of 17-OHPC in adult female Sprague Dawley rats and female New Zealand rabbits.Gels containing 17-OHPC were administered intravaginally to rats and rabbits for 10 consecutive days. After the last dose, serial blood samples and terminal uterine and adipose tissue samples were collected. 17-OHPC concentrations were measured by LC-MS-MS.Tissue histology showed that intravaginal administration of 17-OHPC was safe. There was no renal or hepatic toxicity as measured by liver function and kidney function tests.Intravaginal administration of 17-OHPC resulted in low systemic plasma concentrations but substantially higher uterus and adipose tissue concentrations of 17-OHPC. Composition of the formulation affected the tissue distribution of 17-OHPC.Future studies warrant further evaluation of the effect and safety of daily intravaginal administration of 17-OHPC gel in pregnant animals.

Indexed as

17 alpha-Hydroxyprogesterone CaproateRats, Sprague-DawleyAdministration, IntravaginalAnimalsFemaleHydroxyprogesteronesPregnancyRabbitsRatsUterus17 alpha-Hydroxyprogesterone CaproateHydroxyprogesterones17-hydroxyprogesterone caproateintravaginal gellocal deliverymucoloxPreterm birthReplens®

Identifiers

PMID39584456
PMCPMC11750048

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.