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Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study.
Clin Drug Investig. 2010; 30(4):211-20.CD

Abstract

BACKGROUND

In clinical trials and non-interventional studies encompassing > 50,000 women, the monophasic, low-dose combined oral contraceptive (OC) chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (CMA/EE) has been shown to have various non-contraceptive benefits, as well as contraceptive efficacy and good tolerability. However, there is a paucity of data on use of this OC in young women.

OBJECTIVE

To investigate the relevance of, and changes in, cycle disorders, dysmenorrhoea and skin problems in addition to the efficacy and tolerability of CMA/EE in young women.

METHODS

In this prospective, observational, non-interventional, multicentre study (TeeNIS [Teenager in Non-Interventional Study 2 mg CMA/0.03 mg EE]), young women (< or =20 years of age) were administered CMA/EE (Belara) once daily for 21 days (one blister strip), followed by either a 7-day pill-free interval (conventional cycle regimen; 89.3%) or a pill-free interval after two blister strips or more (extended cycle regimen; 3.7%), over a 6-month treatment period. Data on the mode of administration were missing for 7.1% of patients. The study included a safety population of 7462 patients (the efficacy population consisted of 6885 patients) from 886 gynaecological centres throughout Germany.

RESULTS

Compared with baseline, CMA/EE intake resulted in significant reductions in the numbers of patients with cycle disorders, i.e. spotting (-46%), breakthrough bleeding (-64%), heavy bleeding (-95%) and absence of any bleeding (secondary amenorrhoea; -76%) [all p < or = 0.001], and with dysmenorrhoea (-56%) [p < or = 0.001]. Similarly, there was a significant decrease in the number of patients who used analgesics (-75%), had dysmenorrhoea-associated symptoms (back pain [-69%], headache [-70%], nausea/vomiting [-85%], diarrhoea [-80%], mood swings [-75%] or absence from school/job due to dysmenorrhoea [-92%]), or were restricted in their leisure/sporting activities because of dysmenorrhoea (-83%) [all p < or = 0.001]. Another major benefit of CMA/EE was a significant reduction in the number of patients with skin problems (acne and acne-prone skin) [-55%; p < or = 0.001]. In parallel, the number of patients who needed dermatological treatment (-67%; p < or = 0.001) and concealer cosmetics (-55%; p < or = 0.001) was significantly reduced, and significantly fewer patients felt that their self-esteem was restricted due to skin problems (-67%; p < or = 0.001). There were no relevant weight changes during the observation period; mean bodyweight remained virtually constant (mean weight change <1 kg). At final assessment, physicians' expectations were either 'completely fulfilled' or 'exceeded' with regard to cycle stability, regular bleeding, dysmenorrhoea, effects on weight, and skin problems in 78-95% of patients. CMA/EE provided high contraceptive efficacy with an unadjusted Pearl index of 0.25, calculated from 41 601 cycles of exposure; seven out of eight pregnancies were attributable to user failure, thus resulting in an adjusted Pearl index of 0.03. The tolerability of CMA/EE was excellent, with no unexpected adverse effects.

CONCLUSIONS

This observational, non-interventional study in young women showed that CMA/EE had a significantly beneficial effect on cycle disorders, dysmenorrhoea and skin disorders, and confirmed the good efficacy and tolerability of this combined OC.

Authors+Show Affiliations

Klinikum der Universität München-Grosshadern, Munich, Germany. Sabine.Anthuber@med.uni-muenchen.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20225905

Citation

Anthuber, Sabine, et al. "Six-month Evaluation of the Benefits of the Low-dose Combined Oral Contraceptive Chlormadinone Acetate 2 Mg/ethinylestradiol 0.03 Mg in Young Women: Results of the Prospective, Observational, Non-interventional, Multicentre TeeNIS Study." Clinical Drug Investigation, vol. 30, no. 4, 2010, pp. 211-20.
Anthuber S, Schramm GA, Heskamp ML. Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study. Clin Drug Investig. 2010;30(4):211-20.
Anthuber, S., Schramm, G. A., & Heskamp, M. L. (2010). Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study. Clinical Drug Investigation, 30(4), 211-20. https://doi.org/10.2165/11532910-000000000-00000
Anthuber S, Schramm GA, Heskamp ML. Six-month Evaluation of the Benefits of the Low-dose Combined Oral Contraceptive Chlormadinone Acetate 2 Mg/ethinylestradiol 0.03 Mg in Young Women: Results of the Prospective, Observational, Non-interventional, Multicentre TeeNIS Study. Clin Drug Investig. 2010;30(4):211-20. PubMed PMID: 20225905.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study. AU - Anthuber,Sabine, AU - Schramm,Georg A K, AU - Heskamp,Marie-Luise S, PY - 2010/3/16/entrez PY - 2010/3/17/pubmed PY - 2010/5/14/medline SP - 211 EP - 20 JF - Clinical drug investigation JO - Clin Drug Investig VL - 30 IS - 4 N2 - BACKGROUND: In clinical trials and non-interventional studies encompassing > 50,000 women, the monophasic, low-dose combined oral contraceptive (OC) chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (CMA/EE) has been shown to have various non-contraceptive benefits, as well as contraceptive efficacy and good tolerability. However, there is a paucity of data on use of this OC in young women. OBJECTIVE: To investigate the relevance of, and changes in, cycle disorders, dysmenorrhoea and skin problems in addition to the efficacy and tolerability of CMA/EE in young women. METHODS: In this prospective, observational, non-interventional, multicentre study (TeeNIS [Teenager in Non-Interventional Study 2 mg CMA/0.03 mg EE]), young women (< or =20 years of age) were administered CMA/EE (Belara) once daily for 21 days (one blister strip), followed by either a 7-day pill-free interval (conventional cycle regimen; 89.3%) or a pill-free interval after two blister strips or more (extended cycle regimen; 3.7%), over a 6-month treatment period. Data on the mode of administration were missing for 7.1% of patients. The study included a safety population of 7462 patients (the efficacy population consisted of 6885 patients) from 886 gynaecological centres throughout Germany. RESULTS: Compared with baseline, CMA/EE intake resulted in significant reductions in the numbers of patients with cycle disorders, i.e. spotting (-46%), breakthrough bleeding (-64%), heavy bleeding (-95%) and absence of any bleeding (secondary amenorrhoea; -76%) [all p < or = 0.001], and with dysmenorrhoea (-56%) [p < or = 0.001]. Similarly, there was a significant decrease in the number of patients who used analgesics (-75%), had dysmenorrhoea-associated symptoms (back pain [-69%], headache [-70%], nausea/vomiting [-85%], diarrhoea [-80%], mood swings [-75%] or absence from school/job due to dysmenorrhoea [-92%]), or were restricted in their leisure/sporting activities because of dysmenorrhoea (-83%) [all p < or = 0.001]. Another major benefit of CMA/EE was a significant reduction in the number of patients with skin problems (acne and acne-prone skin) [-55%; p < or = 0.001]. In parallel, the number of patients who needed dermatological treatment (-67%; p < or = 0.001) and concealer cosmetics (-55%; p < or = 0.001) was significantly reduced, and significantly fewer patients felt that their self-esteem was restricted due to skin problems (-67%; p < or = 0.001). There were no relevant weight changes during the observation period; mean bodyweight remained virtually constant (mean weight change <1 kg). At final assessment, physicians' expectations were either 'completely fulfilled' or 'exceeded' with regard to cycle stability, regular bleeding, dysmenorrhoea, effects on weight, and skin problems in 78-95% of patients. CMA/EE provided high contraceptive efficacy with an unadjusted Pearl index of 0.25, calculated from 41 601 cycles of exposure; seven out of eight pregnancies were attributable to user failure, thus resulting in an adjusted Pearl index of 0.03. The tolerability of CMA/EE was excellent, with no unexpected adverse effects. CONCLUSIONS: This observational, non-interventional study in young women showed that CMA/EE had a significantly beneficial effect on cycle disorders, dysmenorrhoea and skin disorders, and confirmed the good efficacy and tolerability of this combined OC. SN - 1173-2563 UR - https://www.unboundmedicine.com/medline/citation/20225905/Six_month_evaluation_of_the_benefits_of_the_low_dose_combined_oral_contraceptive_chlormadinone_acetate_2_mg/ethinylestradiol_0_03_mg_in_young_women:_results_of_the_prospective_observational_non_interventional_multicentre_TeeNIS_study_ L2 - https://dx.doi.org/10.2165/11532910-000000000-00000 DB - PRIME DP - Unbound Medicine ER -