Use of a monophasic, low-dose oral contraceptive in relation to mental functioning.

The objective of the study was to evaluate the effect of Minulet, a new low-dose oral contraceptive on mood in two groups and to compare the effect with a control group of women not taking oral contraceptives (OC). The women participating were between 16 and 45 years of age. They completed the Amsterdam Mood Questionnaire (AMQ) and the Sickness Impact Profile (SIP) three times. They were filled in before treatment started, after taking Minulet for one month and then again after three months. The questionnaires were filled in by a group of 200 women who had not taken OC before (starters), and by a second group of 370 women who were already taking OC (switchers). A group of 140 women who did not use any OC during the study served as a control group. These women also filled in the same questionnaires, both at the start, and after one and three months. As far as the AMQ was concerned, the switchers appeared in the initial measurement to have significantly higher scores (that is to say, a worse mood) for "tiredness", "depression", "moodiness", "anxiety" and "anger", than those of the starters and the control group. Moreover, the switchers had reduced scores (that is to say, an improved mood) on the AMQ-scales during their use of Minulet compared to their initial use of oral contraceptives. The scores of the starters and the control group on the AMQ-scales remained unchanged on all three measurements. It can be concluded from this that these groups felt as well as they did before.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: In the Netherlands, researchers compared data on 195 16-45 year old women who had never used oral contraceptives (OS) and started taking the low-dose OC Minulet (75 mcg gestodene and 30 mcg ethinyl estradiol) (starters) with data on 363 16-45 year old women who had used another OC, then began taking Minulet (switchers), and with data on 139 16-45 year old women who had not used and were currently not using any OC (controls) to examine Minulet's effect on mood. Switchers had higher scores on the Amsterdam Mood Questionnaire (AMQ) for tiredness, depression, moodiness, anxiety, and anger (i.e., a worse mood) than both the starters and controls. Yet, after taking Minulet, the same AMQ scores for switchers fell significantly (i.e., an improved mood). On the other hand, the scores of both the controls and the starters were the same for all 3 measurements (before use, 1 month after use, and 3 months after use). Further, the original Sickness Impact Profile (SIP) scores of switchers revealed significantly more problems with emotional behavior, social interaction, and alertness than the controls. Only the initial social interaction score was significantly different compared to that of starters. After using Minulet, the switchers' SIP scores improved, while the SIP scores of the controls and starters remained the same. Therefore, Minulet did not affect the mood of the starters and significantly improved the psychosocial functioning of women who had used other OCs.

The acceptance of a 7-week cycle with a modern low-dose oral contraceptive (Minulet).

Cycle control and tolerance were studied in a group of 55 female volunteers, who took during 42 consecutive days a modern low-dose oral contraceptive: gestodene 75 micrograms/ethinylestradiol 30 micrograms (Minulet). During these 42 days, 96% of the women experienced no breakthrough bleeding and 81% of the women experienced no spotting or breakthrough bleeding. When the findings of this study are compared with the findings of an earlier study with also a seven-week cycle but with other oral contraceptives, it can be concluded that Minulet offered an excellent cycle control.

PIP: 55 women took the combined oral contraceptive Minulet (30 mcg ethinyl estradiol and 75 mcg gestodene) for 42 consecutive days, using 2 active pill strips, to lengthen the interval between withdrawal bleeding and assess acceptability. The study was an open multi-center trial in which 38 general practitioners each supervised 1 or 2 women. The women averaged 27 years old (range 18-40), and had used Minulet without problems for the previous 6 months. 10 women noted spotting, and 2 had breakthrough bleeding, both after Day 21 of pill intake. There was 1 dropout for unrelated medical reasons. Other minor side effects were breast tenderness (7%), nausea (4%), abdominal bloating (4%), headache (2%), and dysmenorrhea (2%). 92% of the women reported extreme to moderate satisfaction, but 4% were not satisfied because of breakthrough bleeding. Nevertheless, these data on breakthrough bleeding were much lower than published data from trials with other combined pills, especially those containing levonorgestrel.