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Clinical experience with a modern low-dose oral contraceptive in almost 100,000 users.
Contraception. 1991 Feb; 43(2):101-10.C

Abstract

Efficacy, cycle control, tolerance, and adverse events were studied in a clinical Phase IV study using a new progestogen, gestodene, in an amount of 75 micrograms combined with 30 micrograms ethinylestradiol. The study was performed as a multicenter trial in 96,000 patients over a period of 6 cycles. Half of the patients taking the new preparation were first-time OC users, the other half switched from another OC. With regard to contraceptive efficacy, the life-table analysis showed a value of 0.032% for method failure and 0.114% for patient failure. The correspondent Pearl-Index is 0.062 and 0.22. The new drug was found acceptable by more than 90% of the women involved in the trial. Dysmenorrhea present in the "switchers" mostly disappeared on the new OC, while body weight and blood pressure remained virtually unchanged. Thus, it can be concluded that blood pressure and body weight behaviour is similar to that seen with other low-dose OCs. The new combined pill offers excellent cycle stability and has a very favourable effect on dysmenorrhea. The number of clinically diagnosed thrombotic events documented in this study was 0.65 per 1000 woman-years (TWY) and does not exceed the range of events seen in groups of women using non-hormonal methods of contraception (Oxford-FPA study 0.4/TWY and RCGP study 0.8/TWY).

Authors+Show Affiliations

Medical Dept., Schering AG, Berlin, FR Germany.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

2040166

Citation

Brill, K, et al. "Clinical Experience With a Modern Low-dose Oral Contraceptive in Almost 100,000 Users." Contraception, vol. 43, no. 2, 1991, pp. 101-10.
Brill K, Norpoth T, Schnitker J, et al. Clinical experience with a modern low-dose oral contraceptive in almost 100,000 users. Contraception. 1991;43(2):101-10.
Brill, K., Norpoth, T., Schnitker, J., & Albring, M. (1991). Clinical experience with a modern low-dose oral contraceptive in almost 100,000 users. Contraception, 43(2), 101-10.
Brill K, et al. Clinical Experience With a Modern Low-dose Oral Contraceptive in Almost 100,000 Users. Contraception. 1991;43(2):101-10. PubMed PMID: 2040166.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical experience with a modern low-dose oral contraceptive in almost 100,000 users. AU - Brill,K, AU - Norpoth,T, AU - Schnitker,J, AU - Albring,M, PY - 1991/2/1/pubmed PY - 1991/2/1/medline PY - 1991/2/1/entrez KW - Biology KW - Bleeding KW - Blood Pressure--changes KW - Body Weight--changes KW - Clinical Research KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Effectiveness KW - Contraceptive Methods--side effects KW - Contraceptive Usage KW - Developed Countries KW - Diseases KW - Embolism KW - Ethinyl Estradiol KW - Europe KW - Evaluation KW - Family Planning KW - Germany, Federal Republic Of KW - Gestodene KW - Hemic System KW - Incidence KW - Measurement KW - Menstrual Cycle--changes KW - Menstruation KW - Method Acceptability KW - Oral Contraceptives, Low-dose--side effects KW - Oral Contraceptives--side effects KW - Pearl's Formula KW - Physiology KW - Reproduction KW - Research Methodology KW - Risk Assessment KW - Signs And Symptoms KW - Thromboembolism KW - Use-effectiveness KW - Vascular Diseases KW - Western Europe SP - 101 EP - 10 JF - Contraception JO - Contraception VL - 43 IS - 2 N2 - Efficacy, cycle control, tolerance, and adverse events were studied in a clinical Phase IV study using a new progestogen, gestodene, in an amount of 75 micrograms combined with 30 micrograms ethinylestradiol. The study was performed as a multicenter trial in 96,000 patients over a period of 6 cycles. Half of the patients taking the new preparation were first-time OC users, the other half switched from another OC. With regard to contraceptive efficacy, the life-table analysis showed a value of 0.032% for method failure and 0.114% for patient failure. The correspondent Pearl-Index is 0.062 and 0.22. The new drug was found acceptable by more than 90% of the women involved in the trial. Dysmenorrhea present in the "switchers" mostly disappeared on the new OC, while body weight and blood pressure remained virtually unchanged. Thus, it can be concluded that blood pressure and body weight behaviour is similar to that seen with other low-dose OCs. The new combined pill offers excellent cycle stability and has a very favourable effect on dysmenorrhea. The number of clinically diagnosed thrombotic events documented in this study was 0.65 per 1000 woman-years (TWY) and does not exceed the range of events seen in groups of women using non-hormonal methods of contraception (Oxford-FPA study 0.4/TWY and RCGP study 0.8/TWY). SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/2040166/Clinical_experience_with_a_modern_low_dose_oral_contraceptive_in_almost_100000_users_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0010-7824(91)90037-G DB - PRIME DP - Unbound Medicine ER -