Evidence map›Paper›PMID 30831102›Full record

Trial reportContraception2019

Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.

Kristina Gemzell-Danielsson, Regine Sitruk-Ware, Mitchell D Creinin, Michael Thomas, Kurt T Barnhart, George Creasy, Heather Sussman, Mohcine Alami, Anne E Burke, Edith Weisberg and 8 more

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contraception, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Low Thrombin Generation in Users of a Contraceptive Containing Estetrol and Drospirenone.The Journal of clinical endocrinology and metabolism · 2022
    Article
  10. New Contraception Update - Annovera, Phexxi, Slynd, and Twirla.Current obstetrics and gynecology reports · 2022
    Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Advances in contraception: vaginal contraceptive rings.Therapeutic advances in reproductive health
    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

18 authors.

Kristina Gemzell-DanielssonDepartment of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden. Electronic address: kristina.gemzell@ki.se.
Regine Sitruk-WareCenter for Biomedical Research, Population Council, New York, NY, USA.
Mitchell D CreininDepartment of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.
Michael ThomasDepartment of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, OH, USA.
Kurt T BarnhartDepartment of Obstetrics and Gynecology, Perelman School of medicine, University of Pennsylvania, Philadelphia, PA, USA.
George CreasyCenter for Biomedical Research, Population Council, New York, NY, USA.
Heather SussmanCenter for Biomedical Research, Population Council, New York, NY, USA.
Mohcine AlamiCenter for Biomedical Research, Population Council, New York, NY, USA.
Anne E BurkeDepartment of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Bayview Medical Center, Baltimore, MD, USA.
Edith WeisbergFamily Planning NSW, and University of Sydney, Sydney, Australia.
Ian FraserUniversity of New South Wales; Family Planning NSW, and University of Sydney, Sydney, Australia.
Marie-José MirandaInstituto Chileno de Medicina Reproductiva (ICMER), Santiago, Chile.
Melissa GilliamDepartment of Obstetrics, Gynecology and Pediatrics, University of Chicago, Chicago, IL, USA.
James LiuDepartment of Obstetrics and Gynecology, Case Western Reserve University, Cleveland, OH, USA.
Bruce R CarrUT Southwestern University, Dallas, TX, USA.
Marlena PlagianosCenter for Biomedical Research, Population Council, New York, NY, USA.
Kevin RobertsCenter for Biomedical Research, Population Council, New York, NY, USA.
Diana BlitheEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.

Funding

Development of novel contraceptive methods for men and womenZIBHD008987 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI BLITHE, DIANA · 2019 to 2025
$7.2M
Intramural NIH HHS Z99 HD999999
6 · The paper itself

Abstract

objectivesTo evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily. STUDY

designWe integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies.

resultsThe combined studies included 3052 women; 2308 women [mean age 26.7±5.1 years; mean body mass index (BMI) 24.1±3.7 kg/m

conclusionThe 1-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE. IMPLICATIONS: This 1-year contraceptive vaginal system represents a new long-term, user-controlled and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.

Indexed as

AdultContraceptive Devices, FemaleDrug CombinationsEthinyl EstradiolFemaleHumansPregnenedionesYoung AdultDrug CombinationsEthinyl EstradiolPregnenedionessegesterone acetate and ethinyl estradiol vaginal systemAdverse eventsContraceptive vaginal systemEthinyl estradiolNestoroneSegesterone acetate

Identifiers

PMID30831102
PMCPMC7357828

What OpenQuestion holds

Textmetadata
LicenceTDM
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.