Evidence map›Paper›PMID 31728664›Full record

Trial reportArchives of gynecology and obstetrics2019

A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.

Santiago Palacios, Enrico Colli, Pedro-Antonio Regidor

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Observational
  6. Article
  7. Article
  8. Progestogen-only oral contraceptives.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2022
    Article
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Santiago PalaciosInstituto Palacios, Salud y Medicina de la Mujer, C/ Antonio Acuña, 9, 28009, Madrid, Spain.
Enrico ColliExeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.
Pedro-Antonio RegidorExeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.
Instituto Palacios · ESMadrid Health Service · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use.

methodsA drospirenone (DRSP)-only pill was developed to improve the bleeding profile.

settingA phase III study in healthy women aged 18-45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles. POPULATION: A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed.

main outcome measuresThe primary end point was the proportion of women with unscheduled bleeding/spotting in each cycle from cycles 2 to 9 and cumulative in cycles 2-4 and cycles 7-9.

resultsIn each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).

conclusionsThis report describes the improvement in bleeding profile of women using the new DRSP-only oral contraceptive in comparison to DSG, providing a better quality of live and adherence to the contraceptive method. EudraCT Registration Number: 2011-002396-42.

Indexed as

AdolescentAdultAndrostenesContraceptionContraceptives, OralDesogestrelDouble-Blind MethodFemaleHumansMetrorrhagiaMiddle AgedYoung AdultAndrostenesContraceptives, OralDesogestreldrospirenoneBleedingCycle controlDrospirenone only pill

Identifiers

PMID31728664
PMCPMC7174261
OpenAlexW4255156894

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.