Tags

Type your tag names separated by a space and hit enter

Open prospective multicenter trial with a new monophasic contraceptive combination containing gestodene.
Contraception. 1991 May; 43(5):413-21.C

Abstract

In a large and open prospective multicenter trial of 12,250 cycles from 2,378 women, contraceptive efficacy, clinical tolerance and acceptability of a new monophasic contraceptive combination containing 75 mcg gestodene (delta-5-levonorgestrel) and 30 mcg ethinyl oestradiol were studied. The objective was to assess efficacy, safety, side effects and cycle control of this oral contraceptive on healthy women using no other additional birth control methods. Two women became pregnant (0.016%) during the trial; both were patient failures. There was no effect on systolic or diastolic pressures. An average weight increase of 0.3 kg was noted. Cycle control was excellent with 95% of the cycles free of spotting and 98% free of breakthrough bleeding after six cycles. No serious complications occurred. There was an overall incidence of 14% reported side effects (after six cycles), indicating that the hormonal combination is well tolerated. It should be noted that 41.4% of the patients had some complaint before starting the treatment. For all complaints, a highly significant improvement was seen during the treatment.

Authors+Show Affiliations

University Hospital, Antwerp, Belgium.No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

1914456

Citation

Renier, M, and P Buytaert. "Open Prospective Multicenter Trial With a New Monophasic Contraceptive Combination Containing Gestodene." Contraception, vol. 43, no. 5, 1991, pp. 413-21.
Renier M, Buytaert P. Open prospective multicenter trial with a new monophasic contraceptive combination containing gestodene. Contraception. 1991;43(5):413-21.
Renier, M., & Buytaert, P. (1991). Open prospective multicenter trial with a new monophasic contraceptive combination containing gestodene. Contraception, 43(5), 413-21.
Renier M, Buytaert P. Open Prospective Multicenter Trial With a New Monophasic Contraceptive Combination Containing Gestodene. Contraception. 1991;43(5):413-21. PubMed PMID: 1914456.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Open prospective multicenter trial with a new monophasic contraceptive combination containing gestodene. AU - Renier,M, AU - Buytaert,P, PY - 1991/5/1/pubmed PY - 1991/5/1/medline PY - 1991/5/1/entrez KW - Acceptor Characteristics KW - Acceptors KW - Belgium KW - Biology KW - Bleeding KW - Blood Pressure--changes KW - Contraception KW - Contraception Termination KW - Contraceptive Agents, Estrogen--side effects KW - Contraceptive Agents, Female--side effects KW - Contraceptive Agents, Progestin--side effects KW - Contraceptive Agents--side effects KW - Contraceptive Effectiveness KW - Contraceptive Methods--side effects KW - Contraceptive Usage KW - Developed Countries KW - Diseases KW - Ethinyl Estradiol--side effects KW - Europe KW - Family Planning KW - Family Planning Programs KW - Gestodene--side effects KW - Hemic System KW - Menstrual Cycle--changes KW - Menstruation KW - Method Acceptability KW - Oral Contraceptives, Combined--side effects KW - Oral Contraceptives--side effects KW - Physiology KW - Prospective Studies KW - Reproduction KW - Research Methodology KW - Signs And Symptoms KW - Studies KW - Western Europe SP - 413 EP - 21 JF - Contraception JO - Contraception VL - 43 IS - 5 N2 - In a large and open prospective multicenter trial of 12,250 cycles from 2,378 women, contraceptive efficacy, clinical tolerance and acceptability of a new monophasic contraceptive combination containing 75 mcg gestodene (delta-5-levonorgestrel) and 30 mcg ethinyl oestradiol were studied. The objective was to assess efficacy, safety, side effects and cycle control of this oral contraceptive on healthy women using no other additional birth control methods. Two women became pregnant (0.016%) during the trial; both were patient failures. There was no effect on systolic or diastolic pressures. An average weight increase of 0.3 kg was noted. Cycle control was excellent with 95% of the cycles free of spotting and 98% free of breakthrough bleeding after six cycles. No serious complications occurred. There was an overall incidence of 14% reported side effects (after six cycles), indicating that the hormonal combination is well tolerated. It should be noted that 41.4% of the patients had some complaint before starting the treatment. For all complaints, a highly significant improvement was seen during the treatment. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/1914456/Open_prospective_multicenter_trial_with_a_new_monophasic_contraceptive_combination_containing_gestodene_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0010-7824(91)90132-Y DB - PRIME DP - Unbound Medicine ER -