Trial reportActa obstetricia et gynecologica Scandinavica2019
Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill.
Trial report in Acta obstetricia et gynecologica Scandinavica, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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.
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.
Who cites it
23 citing papers in PubMed, 73 citations in OpenAlex.
- Safety and Efficacy of a 24-Cycle Administration of a Drospirenone-Only Pill in Japanese Women.The journal of obstetrics and gynaecology research · 2026Trial
- Efficacy and safety of drospirenone as a progestin-only pill in Japanese women: A phase III study.The journal of obstetrics and gynaecology research · 2025Trial
- Evaluation of the food effect on a drospirenone only contraceptive containing 4 mg administered with and without high-fat breakfast in a randomised trial.BMC women's health · 2022Trial
- Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.BMC women's health · 2020Trial
- Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill.Acta obstetricia et gynecologica Scandinavica · 2019Trial
- Cardiometabolic, Glycaemic, and Metabolic Safety of Hormonal Contraceptives in Women with Medical Conditions: A Systematic Review.International journal of women's health · 2026Review
- A detailed review of pharmacokinetics/pharmacodynamics of progestogens in oral contraception.Frontiers in endocrinology · 2026Review
- Therapeutic selection for abnormal uterine bleeding with ovulatory dysfunction: a cross-sectional study in Chinese women.Future science OA · 2025Article
- Progestins - a review of clinical application in gynecology.Annals of medicine · 2025Review
- Use of progestin-only drospirenone-based pills in hyperandrogenic women with polycystic ovary syndrome.Archives of gynecology and obstetrics · 2025Observational
- Management of abnormal bleeding in etonogestrel-releasing implant users: quo vadis? An exploratory study on the attitudes of a cohort of Italian gynaecologists and review of the literature.Contraception and reproductive medicine · 2025Review
- Anamnesis Checklist for Informed Oral Contraceptive Choices: A Spanish Perspective.Women's health reports (New Rochelle, N.Y.) · 2025Article
- Safety of Progestogen Hormonal Contraceptive Methods during Lactation: An Overview.Clinics and practice · 2024Review
- Pregnancy Considerations in Tetralogy of Fallot.CJC pediatric and congenital heart disease · 2023Review
- The benefits of estetrol addition to drospirenone for contraception.AJOG global reports · 2023Article
- Low Thrombin Generation in Users of a Contraceptive Containing Estetrol and Drospirenone.The Journal of clinical endocrinology and metabolism · 2022Article
- Progestogen-only oral contraceptives.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2022Article
- New Contraception Update - Annovera, Phexxi, Slynd, and Twirla.Current obstetrics and gynecology reports · 2022Article
- Oral Progestins in Hormonal Contraception: Importance and Future Perspectives of a New Progestin Only-Pill Containing 4 mg Drospirenone.Geburtshilfe und Frauenheilkunde · 2021Article
- Hormonal Contraceptives and Dermatology.American journal of clinical dermatology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
Abstract
introductionApproximately 100 million women currently use combined oral contraceptives. Combined oral contraceptives use is associated with increased risk of venous thromboembolic events and cardiovascular disease. Progestin-only pills do not increase the risk of venous thromboembolic events, stroke and myocardial infarction but are associated with a poor cycle control. A novel estrogen-free pill containing only drospirenone (DRSP) was developed to improve bleeding pattern, tolerability and acceptance without increasing venous thromboembolic events risks in contraception. MATERIAL AND
methodsTwo prospective, multicenter Phase III studies in healthy women aged 18-45 years were performed to demonstrate the efficacy and safety of a drospirenone-only pill in a regimen of 24 days of 4 mg of drospirenone tablets followed by 4 days of placebo. A total of 1571 women (14 329 exposure cycles) were analyzed: 713 patients in the 13-cycle study 1 with 7638 exposure cycles and 858 patients in the 9-cycle study 2 with 6691 exposure cycles. The primary endpoint was the overall Pearl index, calculated for each study separately, and for both pooled. As main secondary efficacy endpoint, the "method failure Pearl index" including all pregnancies during "perfect medication cycles" was evaluated. EudraCT registration numbers: 2010-021787-15 & 2011-002396-42.
resultsCalculations on pooled studies 1 and 2 with 1571 patients gave an overall Pearl index (based on 14 329 cycles) of 0.7258 (95% CI 0.3133 to 1.4301). No single case of deep vein thrombosis or pulmonary embolism and only one case of hyperkalemia were reported. Additional information such as laboratory parameters, body mass index, bodyweight, heart rate and blood pressure showed no statistically significant changes due to the treatment.
conclusionsThis is the first report of a new drospirenone-only oral contraceptive providing clinical efficacy similar to combined oral contraceptives, with a good safety profile, and favorable cycle control.
Indexed as
Identifiers
What OpenQuestion holds
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.