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Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol.

Abstract

OBJECTIVE

To compare two oral contraceptive pills, both containing 150 micrograms desogestrel, but with either 20 micrograms (Mercilon) or 30 micrograms (Marvelon/Desolett) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile.

DESIGN

A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards.

SETTING

University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark.

SUBJECTS

One thousand women aged 18 to 40 years requesting oral contraceptive pills.

MAIN OUTCOME MEASURES

Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin.

RESULTS

In a total of 4543 cycles with the 20 micrograms EE dose pill and 4688 cycles with the 30 micrograms EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial.

CONCLUSIONS

Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding.

Authors+Show Affiliations

,

Student Gynaecology Clinic, Lund, Sweden.

,

Source

MeSH

Adolescent
Adult
Body Weight
Chemistry, Pharmaceutical
Contraceptives, Oral, Combined
Desogestrel
Double-Blind Method
Ethinyl Estradiol
Female
Humans
Menstrual Cycle
Pancuronium
Risk Factors

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8218004

Citation

Akerlund, M, et al. "Comparative Profiles of Reliability, Cycle Control and Side Effects of Two Oral Contraceptive Formulations Containing 150 Micrograms Desogestrel and Either 30 Micrograms or 20 Micrograms Ethinyl Oestradiol." British Journal of Obstetrics and Gynaecology, vol. 100, no. 9, 1993, pp. 832-8.
Akerlund M, Røde A, Westergaard J. Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol. Br J Obstet Gynaecol. 1993;100(9):832-8.
Akerlund, M., Røde, A., & Westergaard, J. (1993). Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol. British Journal of Obstetrics and Gynaecology, 100(9), pp. 832-8.
Akerlund M, Røde A, Westergaard J. Comparative Profiles of Reliability, Cycle Control and Side Effects of Two Oral Contraceptive Formulations Containing 150 Micrograms Desogestrel and Either 30 Micrograms or 20 Micrograms Ethinyl Oestradiol. Br J Obstet Gynaecol. 1993;100(9):832-8. PubMed PMID: 8218004.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol. AU - Akerlund,M, AU - Røde,A, AU - Westergaard,J, PY - 1993/9/1/pubmed PY - 1993/9/1/medline PY - 1993/9/1/entrez KW - Amenorrhea KW - Biology KW - Bleeding KW - Blood Pressure KW - Body Weight KW - Comparative Studies KW - Contraception KW - Contraception Failure KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Method Switching KW - Contraceptive Methods--administraction and dosage KW - Contraceptive Methods--side effects KW - Contraceptive Usage KW - Denmark KW - Desogestrel KW - Developed Countries KW - Diseases KW - Dizziness KW - Double-blind Studies KW - Ethinyl Estradiol KW - Europe KW - Family Planning KW - Headache KW - Hemic System KW - Hemoglobin Level KW - Menorrhagia KW - Menstruation Disorders KW - Method Acceptability KW - Metrorrhagia KW - Northern Europe KW - Norway KW - Oral Contraceptives, Low-dose--administraction and dosage KW - Oral Contraceptives, Low-dose--side effects KW - Oral Contraceptives--administraction and dosage KW - Oral Contraceptives--side effects KW - Physiology KW - Research Methodology KW - Research Report KW - Scandinavia KW - Signs And Symptoms KW - Studies KW - Sweden SP - 832 EP - 8 JF - British journal of obstetrics and gynaecology JO - Br J Obstet Gynaecol VL - 100 IS - 9 N2 - OBJECTIVE: To compare two oral contraceptive pills, both containing 150 micrograms desogestrel, but with either 20 micrograms (Mercilon) or 30 micrograms (Marvelon/Desolett) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile. DESIGN: A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards. SETTING: University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark. SUBJECTS: One thousand women aged 18 to 40 years requesting oral contraceptive pills. MAIN OUTCOME MEASURES: Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin. RESULTS: In a total of 4543 cycles with the 20 micrograms EE dose pill and 4688 cycles with the 30 micrograms EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial. CONCLUSIONS: Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding. SN - 0306-5456 UR - https://www.unboundmedicine.com/medline/citation/8218004/Comparative_profiles_of_reliability_cycle_control_and_side_effects_of_two_oral_contraceptive_formulations_containing_150_micrograms_desogestrel_and_either_30_micrograms_or_20_micrograms_ethinyl_oestradiol_ L2 - https://www.lens.org/lens/search?q=citation_id:8218004 DB - PRIME DP - Unbound Medicine ER -