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Pooled analysis of bleeding profile, efficacy and safety of oral oestradiol valerate/dienogest in women aged 25 and under.

  • Jensen JT Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR, USA.
  • Bitzer J Department of Obstetrics and Gynecology, University Hospitals Basel, Basel, Switzerland.
  • Nappi RE Obstetrics and Gynecology Section of the Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS Policlinico S. Matteo, Pavia, Italy.
  • Ahlers C Bayer AG, Berlin, Germany.
  • Bannemerschult R Bayer AG, Berlin, Germany.
  • Parke S Bayer AG, Berlin, Germany.
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  • 2020-03-13
Published in:
  • The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception. - 2020
Oral contraceptive
bleeding
dienogest
hormone-withdrawal-associated symptoms
oestradiol valerate
safety
young women
English Purpose: To evaluate differences in key outcomes between younger and older women receiving the oral contraceptive oestradiol valerate/dienogest (E2V/DNG).Methods: We conducted a pooled post hoc analysis of primary data from 12 studies of E2V/DNG, stratified by age (≤25 [n = 1309] and >25 [n = 2132] years). Outcomes included safety, efficacy, bleeding profile and hormone-withdrawal-associated symptoms (HWAS). Bleeding and HWAS analyses are also presented for women aged ≤20 years (n = 362). Discontinuations were considered a proxy for patient satisfaction.Results: Results were generally similar for younger and older women. The percentage of women aged ≤25 and >25 years experiencing intracyclic bleeding did not differ between groups (13.4% and 12.8% at cycle 12, respectively), with similar results in women aged ≤20 years (12.7%, cycle 12). Rates of withdrawal bleeding were very similar in women aged ≤25 and >25 years (78.5% and 78.9%, respectively, cycle 12). We also found a similar adjusted Pearl index in the two age groups (0.45 vs 0.57, respectively), similar rates of AEs and HWAS and no difference in discontinuations.Conclusions: Women aged ≤25 and >25 years have a similar experience with an E2V/DNV oral contraceptive, supporting this as an appropriate contraceptive option in younger and older women.
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  • English
Open access status
hybrid
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https://sonar.ch/global/documents/92726
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