Evidence map›Paper›PMID 21995590›Full record

Trial reportThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2011

Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen.

Diana Mansour, Carole Verhoeven, Werner Sommer, Edith Weisberg, Surasak Taneepanichskul, Gian Benedetto Melis, Inger Sundström-Poromaa, Tjeerd Korver

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00511199 (A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive), which is not on this map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
11.3field-weighted citation impact, top 1% 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.

NCT00511199 phase3completednot on this map

A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)

TypeinterventionalSponsorOrganon and CoRan2006 to 2008Enrolled2,152ConditionsContraceptionArmsNOMAC-E2, DRSP-EE
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. Hormonal contraceptives for contraception in overweight or obese women.The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Pooled it
  3. Combined oral contraceptive pills for treatment of acne.The Cochrane database of systematic reviews · 2012
    Pooled it
  4. Review
  5. Review
  6. Abnormal uterine bleeding control with combined oral contraceptives: a review comparing ethinylestradiol and natural hormones.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025
    Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians.The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception · 2016
    Review
  20. Review
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 at 5 institutions in 5 countries.

Diana MansourSexual Health Services, Newcastle Hospitals Community Health, Newcastle upon Tyne, UK. Diana.Mansour@newcastle-pct.nhs.uk
Carole Verhoeven
Werner Sommer
Edith Weisberg
Surasak Taneepanichskul
Gian Benedetto Melis
Inger Sundström-Poromaa
Tjeerd Korver
Merck (Netherlands) · NLChulalongkorn University · THFamily Planning NSW · AUUniversity of Cagliari · ITUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE).

methodsWomen (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n=535) for 13 cycles.

resultsEstimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs.

conclusionsThese data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.

Indexed as

Substance Withdrawal SyndromeAcne VulgarisAdolescentAdultAndrostenesContraceptives, Oral, CombinedContraceptives, Oral, SyntheticEstradiolEstrogensEthinyl EstradiolFemaleHumansMegestrolMenstrual CycleMetrorrhagiaMiddle AgedAndrostenesContraceptives, Oral, CombinedContraceptives, Oral, SyntheticdrospirenoneEstradiolEstrogensEthinyl EstradiolMegestrolMineralocorticoid Receptor Antagonistsnomegestrol acetateNorpregnadienes

Identifiers

PMID21995590
PMCPMC3233274
OpenAlexW2031204208

What OpenQuestion holds

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Registered trials

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.