Evidence map›Paper›PMID 28087972›Full record

ArticleBritish journal of clinical pharmacology2017

Lack of effect of oral cabotegravir on the pharmacokinetics of a levonorgestrel/ethinyl oestradiol-containing oral contraceptive in healthy adult women.

Christine Trezza, Susan L Ford, Elizabeth Gould, Yu Lou, Chuyun Huang, James M Ritter, Ann M Buchanan, William Spreen, Parul Patel

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.3field-weighted citation impact, top 22% of its field
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

16 citing papers in PubMed, 22 citations in OpenAlex.

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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

9 authors at 4 institutions in 2 countries.

Christine TrezzaViiV Healthcare, Research Triangle Park, North Carolina, USA.
Susan L FordPAREXEL International, Research Triangle Park, North Carolina, USA.
Elizabeth GouldPAREXEL International, Research Triangle Park, North Carolina, USA.
Yu LouPAREXEL International, Research Triangle Park, North Carolina, USA.
Chuyun HuangPAREXEL International, Research Triangle Park, North Carolina, USA.
James M RitterQuintiles Drug Research Unit, London, UK.
Ann M BuchananViiV Healthcare, Research Triangle Park, North Carolina, USA.
William SpreenViiV Healthcare, Research Triangle Park, North Carolina, USA.
Parul PatelViiV Healthcare, Research Triangle Park, North Carolina, USA.
Research Triangle Park Foundation · USRTI International · USIQVIA (United Kingdom) · GBPAREXEL International (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis study aimed to investigate whether cabotegravir (CAB), an integrase inhibitor in development for treatment and prevention of human immunodeficiency virus-1, influences the pharmacokinetics (PK) of a levonorgestrel (LNG) and ethinyl oestradiol (EO)-containing oral contraceptive (OC) in healthy women.

methodsIn this open-label, fixed-sequence crossover study, healthy female subjects received LNG 0.15 mg/EO 0.03 mg tablet once daily Days 1-10 alone and with oral CAB 30 mg once daily Days 11-21. At the end of each treatment period, subjects underwent predose sampling for concentrations of follicle-stimulating hormone, luteinizing hormone, and progesterone and serial PK sampling for plasma LNG, EO, and CAB concentrations.

resultsTwenty women were enrolled, and 19 completed the study. One subject was withdrawn due to an adverse event unrelated to study medications. Geometric least squares mean ratios (90% confidence interval) of LNG + CAB vs. LNG alone for LNG area under the plasma concentration-time curve over the dosing interval of duration τ and maximum observed plasma concentration were 1.12 (1.07-1.18) and 1.05 (0.96-1.15), respectively. Geometric least squares mean ratio (90% confidence interval) of EO + CAB vs. EO alone for EO area under the plasma concentration-time curve over the dosing interval of duration τ and maximum observed plasma concentration were 1.02 (0.97-1.08) and 0.92 (0.83-1.03), respectively. Steady-state CAB PK parameters were comparable to historical values. There was no apparent difference in mean luteinizing hormone, follicle-stimulating hormone, and progesterone concentrations between periods. No clinically significant trends in laboratory values, vital signs, or electrocardiography values were observed.

conclusionsRepeat doses of oral CAB had no significant effect on LNG/EO PK or pharmacodynamics, which supports CAB coadministration with LNG/EO OCs in clinical practice.

Indexed as

Administration, OralAdultArea Under CurveContraceptives, Oral, CombinedCross-Over StudiesDiketopiperazinesDrug CombinationsDrug InteractionsEthinyl EstradiolFemaleFollicle Stimulating Hormone, HumanHealthy VolunteersHIV Integrase InhibitorsHumansLevonorgestrelLuteinizing HormonecabotegravirContraceptives, Oral, CombinedDiketopiperazinesDrug CombinationsEthinyl Estradiolethinyl estradiol, levonorgestrel drug combinationFollicle Stimulating Hormone, HumanHIV Integrase InhibitorsLevonorgestrelLuteinizing HormoneProgesteronePyridonescabotegravircontraceptiveethinyl oestradiollevonorgestrelpharmacokinetics

Identifiers

PMID28087972
PMCPMC5465324
OpenAlexW2576899046

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.