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An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen.
Contraception. 2000 Feb; 61(2):105-11.C

Abstract

This open-label, multicenter study evaluated the efficacy, safety, and cycle control of Yasmin, a new low-dose, monophasic oral contraceptive containing the unique progestogen drospirenone (DRSP) 3 mg and ethinyl estradiol (EE) 30 microg. DRSP is a synthetic progestogen that has antiandrogenic and antimineralocorticoid effects. In this study, 326 women were evaluated and 220 (67%) completed all 13 treatment cycles. The corrected Pearl Index was 0. 407. Of the 151 subjects who experienced intermenstrual bleeding at any time during the study, the majority (64%) had bleeding during only one or two pill cycles. Breakthrough bleeding without spotting occurred in 1% of all cycles, spotting without breakthrough bleeding in 9.3% of all cycles, and breakthrough bleeding with spotting in 3% of all cycles. Amenorrhea was observed in 3% of all cycles. In all, 20 subjects (6%) discontinued participation in the study because of adverse events. No serious adverse events related to the study drug were reported. No clinically significant changes in weight, blood pressure, or lipids were reported. The impact of the new progestogen DRSP on the women's self-perception of menstrual health was also evaluated. Subjects reported that symptoms of water retention, negative affect, and increased appetite significantly improved at cycle 6 from baseline. This study demonstrates that Yasmin is an effective oral contraceptive that is safe and well tolerated.

Authors+Show Affiliations

Berlex Laboratories, Montville, New Jersey 07045-1000, USA.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

10802275

Citation

Parsey, K S., and A Pong. "An Open-label, Multicenter Study to Evaluate Yasmin, a Low-dose Combination Oral Contraceptive Containing Drospirenone, a New Progestogen." Contraception, vol. 61, no. 2, 2000, pp. 105-11.
Parsey KS, Pong A. An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception. 2000;61(2):105-11.
Parsey, K. S., & Pong, A. (2000). An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception, 61(2), 105-11.
Parsey KS, Pong A. An Open-label, Multicenter Study to Evaluate Yasmin, a Low-dose Combination Oral Contraceptive Containing Drospirenone, a New Progestogen. Contraception. 2000;61(2):105-11. PubMed PMID: 10802275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. AU - Parsey,K S, AU - Pong,A, PY - 2000/5/10/pubmed PY - 2000/6/10/medline PY - 2000/5/10/entrez KW - Americas KW - Clinical Research KW - Clinical Trials KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Effectiveness KW - Contraceptive Methods KW - Contraceptive Usage KW - Developed Countries KW - Family Planning KW - Health KW - Method Acceptability KW - North America KW - Northern America KW - Oral Contraceptives KW - Oral Contraceptives, Combined KW - Oral Contraceptives, Low-dose KW - Public Health KW - Research Methodology KW - Research Report KW - Safety KW - United States SP - 105 EP - 11 JF - Contraception JO - Contraception VL - 61 IS - 2 N2 - This open-label, multicenter study evaluated the efficacy, safety, and cycle control of Yasmin, a new low-dose, monophasic oral contraceptive containing the unique progestogen drospirenone (DRSP) 3 mg and ethinyl estradiol (EE) 30 microg. DRSP is a synthetic progestogen that has antiandrogenic and antimineralocorticoid effects. In this study, 326 women were evaluated and 220 (67%) completed all 13 treatment cycles. The corrected Pearl Index was 0. 407. Of the 151 subjects who experienced intermenstrual bleeding at any time during the study, the majority (64%) had bleeding during only one or two pill cycles. Breakthrough bleeding without spotting occurred in 1% of all cycles, spotting without breakthrough bleeding in 9.3% of all cycles, and breakthrough bleeding with spotting in 3% of all cycles. Amenorrhea was observed in 3% of all cycles. In all, 20 subjects (6%) discontinued participation in the study because of adverse events. No serious adverse events related to the study drug were reported. No clinically significant changes in weight, blood pressure, or lipids were reported. The impact of the new progestogen DRSP on the women's self-perception of menstrual health was also evaluated. Subjects reported that symptoms of water retention, negative affect, and increased appetite significantly improved at cycle 6 from baseline. This study demonstrates that Yasmin is an effective oral contraceptive that is safe and well tolerated. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/10802275/An_open_label_multicenter_study_to_evaluate_Yasmin_a_low_dose_combination_oral_contraceptive_containing_drospirenone_a_new_progestogen_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(00)00083-4 DB - PRIME DP - Unbound Medicine ER -