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Effect of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception.
Contraception 2006; 74(6):446-50C

Abstract

PURPOSE

Positive effects on premenstrual symptoms have been observed with low-dose oral contraceptives. Drospirenone is a synthetic progestogen with antiandrogenic and antimineralocorticoid effects. This open-label, multicenter study evaluated the effects of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on safety, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception.

MATERIALS AND METHODS

A total of 241 healthy volunteers with symptoms of premenstrual disorder was enrolled in the study. Of the final sample, 203 completed the six-cycle treatment and were included in the efficacy analysis whereas 236 were included in the tolerability analysis. The subjects recruited to the study were required to fill up the Psychological General Well-Being Index (PGWBI).

RESULTS

There was no significant change in body weight or blood pressure throughout the treatment. Adverse events reported by patients during treatment consisted of those already known to be associated with oral contraceptive use. PGWBI scores were significantly higher after six cycles of treatment compared with baseline values (p<.0001). A total of 198 (84.2%) subjects reported a great improvement in premenstrual symptoms.

CONCLUSIONS

The results of this study confirm that oral use of a combination of ethinylestradiol 30 microg and drospirenone 3 mg provides good cycle control, is well tolerated and has a positive impact on symptoms of premenstrual disorder.

Authors+Show Affiliations

Laboratório de Reprodução Humana do Hospital das Clínicas da Universidade Federal de Minas Gerais, Minas Gerais, Brazil.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

17157100

Citation

Borges, Lavínia E., et al. "Effect of a Combination of Ethinylestradiol 30 Microg and Drospirenone 3 Mg On Tolerance, Cycle Control, General Well-being and Fluid-related Symptoms in Women With Premenstrual Disorders Requesting Contraception." Contraception, vol. 74, no. 6, 2006, pp. 446-50.
Borges LE, Andrade RP, Aldrighi JM, et al. Effect of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception. Contraception. 2006;74(6):446-50.
Borges, L. E., Andrade, R. P., Aldrighi, J. M., Guazelli, C., Yazlle, M. E., Isaia, C. F., ... Camargos, A. F. (2006). Effect of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception. Contraception, 74(6), pp. 446-50.
Borges LE, et al. Effect of a Combination of Ethinylestradiol 30 Microg and Drospirenone 3 Mg On Tolerance, Cycle Control, General Well-being and Fluid-related Symptoms in Women With Premenstrual Disorders Requesting Contraception. Contraception. 2006;74(6):446-50. PubMed PMID: 17157100.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception. AU - Borges,Lavínia E, AU - Andrade,Rosires P, AU - Aldrighi,José M, AU - Guazelli,Cristina, AU - Yazlle,Marta Edna H D, AU - Isaia,Carlos F, AU - Petracco,Alvaro, AU - Peixoto,Fabio C, AU - Camargos,Aroldo F, Y1 - 2006/10/19/ PY - 2005/08/03/received PY - 2005/10/30/revised PY - 2005/10/30/accepted PY - 2006/12/13/pubmed PY - 2007/4/18/medline PY - 2006/12/13/entrez SP - 446 EP - 50 JF - Contraception JO - Contraception VL - 74 IS - 6 N2 - PURPOSE: Positive effects on premenstrual symptoms have been observed with low-dose oral contraceptives. Drospirenone is a synthetic progestogen with antiandrogenic and antimineralocorticoid effects. This open-label, multicenter study evaluated the effects of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on safety, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception. MATERIALS AND METHODS: A total of 241 healthy volunteers with symptoms of premenstrual disorder was enrolled in the study. Of the final sample, 203 completed the six-cycle treatment and were included in the efficacy analysis whereas 236 were included in the tolerability analysis. The subjects recruited to the study were required to fill up the Psychological General Well-Being Index (PGWBI). RESULTS: There was no significant change in body weight or blood pressure throughout the treatment. Adverse events reported by patients during treatment consisted of those already known to be associated with oral contraceptive use. PGWBI scores were significantly higher after six cycles of treatment compared with baseline values (p<.0001). A total of 198 (84.2%) subjects reported a great improvement in premenstrual symptoms. CONCLUSIONS: The results of this study confirm that oral use of a combination of ethinylestradiol 30 microg and drospirenone 3 mg provides good cycle control, is well tolerated and has a positive impact on symptoms of premenstrual disorder. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/17157100/Effect_of_a_combination_of_ethinylestradiol_30_microg_and_drospirenone_3_mg_on_tolerance_cycle_control_general_well_being_and_fluid_related_symptoms_in_women_with_premenstrual_disorders_requesting_contraception_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(05)00435-X DB - PRIME DP - Unbound Medicine ER -