Efficacy, cycle control and side-effects of two monophasic combination oral contraceptives: Gestodene/ethinylestradiol and norgestimate/ethinylestradiol

Abstract

Two monophasic oral contraceptives containing gestodene (GTD, 75 micrograms) and ethinylestradiol (EE, 30 micrograms) or norgestimate (NGS, 250 micrograms) and EE (35 micrograms) were compared during the first six cycles of use. The subjects were randomly assigned to receive either type: 97 received GTD/EE and 92 NGS/EE. Six women in the GTD/EE group and nine in the NGS/EE group withdrew from the study; three (3%) and two (2%), respectively, withdrew because of adverse reactions. A total of 562 cycles for GTD/EE and 523 for NGS/EE were available. No woman became pregnant during the study. Overall, 94.4% of cycles in the GTD/EE group and 92.8% in the NGS/EE group were normal. A similar incidence of breakthrough bleeding (0.2% of cycles for GTD and 1.6% for NGS) and spotting (5.4% vs. 5.6%) was observed. Amenorrhea was never reported. Duration of withdrawal bleeding tended to be slightly longer in the NGS/EE group, significantly so for cycles 2 (0.5 days, p = 0.016), 4 (0.5 days, p = 0.031) and 5 (0.4 days, p = 0.045). Cycle 2 was significantly longer in the GTD/EE group (0.3 days, p = 0.027). Side-effects were reported by 12 (12%) women in the GTD/EE group and 13 (14%) in the NGS/EE group. The most common side-effects were headache (five cases (5%) in the GTD/EE group and two (2%) in the NGS/EE group) and breast pain (three (3%) and eight (9%) cases respectively). There were no statistically significant differences between the two groups with respect to change in body weight or changes in blood pressure and in laboratory data.(ABSTRACT TRUNCATED AT 250 WORDS)

Effectiveness and acceptability of progestogens in combined oral contraceptives – a systematic review

“…Endrikat [19] reported both intention-to-treat as well as valid case analysis. The type of analysis was unclear in two studies [18,28]. Post randomization exclusions were not mentioned in fifteen trials.…”

“…This comparison is based on the single study by Affinito [18], including 174 women. No pregnancies were reported in either group at six months of OC use.…”

Contraception and Headache

“…Randomized trials of currently available low‐dose COCs containing ethinylestradiol and different progestins given in cyclical regimens were compared in terms of contraceptive effectiveness, cycle control, and side effects, including headache. Of 30 studies including in the review, 17 reported headache 41‐57. None of the studies reviewed found that any of the progestins compared affected either risk of headache (Supporting Information Table S4) or discontinuation of the COC as a result of headache (Supporting Information Table S5) …”

The paradigm of norgestimate: a third-generation testosterone-derivative progestin with a peripheral anti-androgenic activity and the lowest risk of venous thromboembolism

“…None the studies analyzed found any clinically significant changes in ambulatory blood pressure in the subjects during monophasic EE/NGM treatment [47,50,[59][60][61]. The same trend was observed with the triphasic formulation [49,61].…”

“…Discontinuation because of weight gain during monophasic EE/NGM versus EE/NGL was observed in two different clinical trials: both samples demonstrated a slightly higher rate of discontinuation with NGL (1.4% with EE/NGL versus 1% with EE/NGM, by Corson [50]; 1.54% versus 0.84%, by Andolsek [58]). There were no significant changes in body weight at the end of 6 cycles in a comparative study by Tantbirojn et al (EE/LNG vs. EE/NGM) [59] and of a comparative study by Affinito et al between EE/ GSD and EE/NGM formulations [60]. The triphasic formulation EE/NGM showed the same moderate effects on body weight [49], with a similar effect in comparison with EE/LNG [61].…”