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A comparative study of 35 mcg and 50 mcg combined oral contraceptives: results from a multicenter clinical trial.
Contraception 1991; 44(5):489-503C

Abstract

A comparative multicenter clinical trial of two combined oral contraceptives (OCs) differing only in the estrogen content (35 mcg ethinyl estradiol versus 50 mcg mestranol) was conducted at five clinics located in Yugoslavia, Egypt, Sri Lanka, Costa Rica and Mexico. The trial was designed to determine the differences between Norinyl 1+35 (Syntex) and Norinyl 1+50 (Syntex) in rates and reasons of discontinuation, and frequency of selected side effects which might contribute to method discontinuation. This report includes analysis of 1698 women, all of whom were interval patients (at least 42 days but within 26 weeks postpartum), randomly allocated to one of the above OCs between October 1982 and January 1984. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Significantly more women in the Norinyl 1+35 group (p less than .001) reported intermenstrual bleeding (primarily staining and spotting), as well as an increase in the occurrence of intermenstrual bleeding compared to women in the Norinyl 1+50 group. There were no significant differences between the groups for side effects with the exception of more women in the Norinyl 1+50 group (p less than .05) reporting breast discomfort. The lost to follow-up rate at 12 months was 19.3% for both the Norinyl 1+35 and the Norinyl 1+50 groups. The total discontinuation rate (including women lost to follow-up) at 12 months was 43.5% for the Norinyl 1+35 group and 41.0% for the Norinyl 1+50 group. There were no significant differences between the two groups for gross cumulative life table discontinuation rates (p greater than .05). There were six accidental pregnancies attributed to user failure reported during the study period; four in the Norinyl 1+35 group and two in the Norinyl 1+50 group.

Authors+Show Affiliations

Family Health International, Research Triangle Park, NC 27709.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

1797464

Citation

McLaurin, V L., et al. "A Comparative Study of 35 Mcg and 50 Mcg Combined Oral Contraceptives: Results From a Multicenter Clinical Trial." Contraception, vol. 44, no. 5, 1991, pp. 489-503.
McLaurin VL, Dunson BA, Dunson TR. A comparative study of 35 mcg and 50 mcg combined oral contraceptives: results from a multicenter clinical trial. Contraception. 1991;44(5):489-503.
McLaurin, V. L., Dunson, B. A., & Dunson, T. R. (1991). A comparative study of 35 mcg and 50 mcg combined oral contraceptives: results from a multicenter clinical trial. Contraception, 44(5), pp. 489-503.
McLaurin VL, Dunson BA, Dunson TR. A Comparative Study of 35 Mcg and 50 Mcg Combined Oral Contraceptives: Results From a Multicenter Clinical Trial. Contraception. 1991;44(5):489-503. PubMed PMID: 1797464.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative study of 35 mcg and 50 mcg combined oral contraceptives: results from a multicenter clinical trial. AU - McLaurin,V L, AU - Dunson,B A, AU - Dunson,T R, PY - 1991/11/1/pubmed PY - 1991/11/1/medline PY - 1991/11/1/entrez KW - Africa KW - Americas KW - Arab Countries KW - Asia KW - Central America KW - Comparative Studies KW - Contraception KW - Contraception Failure KW - Contraception Termination--indications KW - Contraception Termination--statistics KW - Contraceptive Agents, Estrogen--administraction and dosage KW - Contraceptive Agents, Female--administraction and dosage KW - Contraceptive Agents--administraction and dosage KW - Contraceptive Methods--side effects KW - Contraceptive Usage--statistics KW - Costa Rica KW - Demographic Factors KW - Developed Countries KW - Developing Countries KW - Egypt KW - Europe KW - Family Planning KW - Fertility KW - Follow-up Studies KW - Incidence KW - Latin America KW - Measurement KW - Mediterranean Countries KW - Menstrual Cycle--changes KW - Menstruation KW - Method Acceptability KW - Mexico KW - North America KW - Northern Africa KW - Oral Contraceptives, Combined--side effects KW - Oral Contraceptives--side effects KW - Population KW - Population Dynamics KW - Pregnancy, Unplanned KW - Reproduction KW - Reproductive Behavior KW - Research Methodology KW - Southern Asia KW - Southern Europe KW - Sri Lanka KW - Studies KW - Yugoslavia SP - 489 EP - 503 JF - Contraception JO - Contraception VL - 44 IS - 5 N2 - A comparative multicenter clinical trial of two combined oral contraceptives (OCs) differing only in the estrogen content (35 mcg ethinyl estradiol versus 50 mcg mestranol) was conducted at five clinics located in Yugoslavia, Egypt, Sri Lanka, Costa Rica and Mexico. The trial was designed to determine the differences between Norinyl 1+35 (Syntex) and Norinyl 1+50 (Syntex) in rates and reasons of discontinuation, and frequency of selected side effects which might contribute to method discontinuation. This report includes analysis of 1698 women, all of whom were interval patients (at least 42 days but within 26 weeks postpartum), randomly allocated to one of the above OCs between October 1982 and January 1984. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Significantly more women in the Norinyl 1+35 group (p less than .001) reported intermenstrual bleeding (primarily staining and spotting), as well as an increase in the occurrence of intermenstrual bleeding compared to women in the Norinyl 1+50 group. There were no significant differences between the groups for side effects with the exception of more women in the Norinyl 1+50 group (p less than .05) reporting breast discomfort. The lost to follow-up rate at 12 months was 19.3% for both the Norinyl 1+35 and the Norinyl 1+50 groups. The total discontinuation rate (including women lost to follow-up) at 12 months was 43.5% for the Norinyl 1+35 group and 41.0% for the Norinyl 1+50 group. There were no significant differences between the two groups for gross cumulative life table discontinuation rates (p greater than .05). There were six accidental pregnancies attributed to user failure reported during the study period; four in the Norinyl 1+35 group and two in the Norinyl 1+50 group. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/1797464/A_comparative_study_of_35_mcg_and_50_mcg_combined_oral_contraceptives:_results_from_a_multicenter_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0010-7824(91)90151-5 DB - PRIME DP - Unbound Medicine ER -