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

Abstract

Objective To compare two oral contraceptive pills, both containing 150 μg desogestrel, but with either 20 μg (Mercilon®) or 30 μg (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 μg EE dose pill and 4688 cycles with the 30 μg EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (breakthrough bleeding or spotting) was signficantly 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.

Improvement of quality of life in women using a low-dose desogestrel-containing contraceptive: results of an observational clinical evaluation

“…However, there were some consistencies: sex life and satisfaction with leisure time activities showed large increases in both studies, and the four items showing the smallest changes (social relationships, family relationships, living situation and vision) were the same in both studies. The improvement in mood seen in this evaluation is consistent with the earlier study of quality of life in users of this OC 11 , but is in contrast to the results of earlier studies with other OCs, which have generally shown a deterioration or no change in mood when first-time users began using a contraceptive [19][20][21][22] .…”

Continuous Oral Contraceptives

“…9 -12 Due to characteristics of their classes, levonorgestrel and norethindrone acetate have distinct biochemical differences: levonorgestrel has higher bioavailability, a longer serum half-life, and a higher relative binding affinity in humans. [13][14][15][16][17] The primary hypothesis of this study was that characteristics of individual progestins, or estrogen dose, may influence the breakthrough bleeding rates with continuously dosed OCs. The ethinyl estradiol (E2) dose may also influence cycle control by counterbalancing the progestin component and stabilizing the endometrium.…”

FSRH Guideline (January 2019, amended October 2023) Combined Hormonal Contraception

“…While some studies have suggested differences in the incidence of mood change between COC formulations (EE dose316, progestogen type336) no consistent trends have been reported. It is possible that formulations containing an anti-androgenic progestogen such as drospirenone337,338 could have a more beneficial effect on mood than preparations containing other progestogens.…”

“…One study merits specific mention. Although criticised in the review for not specifying who was blinded, Akerlund et al (1993)316 undertook an RCT comparing women using a COC containing 150 μg desogestrel with either 20 μg or 30 μg EE. Thus the progestogen component was the same in both groups.…”