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

Abstract

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.

• Authors: Jeffrey T Jensen, Johannes Bitzer, Rossella E Nappi, Christiane Ahlers, Ralf Bannemerschult, Susanne Parke
• Journal: The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (Eur J Contracept Reprod Health Care) Vol. 25 Issue 2 Pg. 98-105 (Apr 2020) ISSN: 1473-0782 [Electronic] England
• PMID: 32162555 (Publication Type: Journal Article)

Chemical References

• Contraceptives, Oral, Combined
• Drug Combinations
• estradiol valerate-dienogest
• Estradiol
• Nandrolone

Topics

• Adolescent
• Adult
• Age Factors
• Clinical Trials, Phase II as Topic
• Clinical Trials, Phase III as Topic
• Contraceptives, Oral, Combined (administration & dosage, adverse effects, therapeutic use)
• Drug Combinations
• Estradiol (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Female
• Humans
• Middle Aged
• Nandrolone (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Patient Satisfaction
• Racial Groups
• Uterine Hemorrhage (chemically induced)
• Young Adult