CONTRACEPTION

THE

ACCEPTANCE LOW-DOSE

OF A -/-WEEK CYCLE ORAL CONTRACEPTIVE

H. Kornaat,

M.H.

Geerdink

WJTH A MODERN (MINULET@)

and J.W.

Klitsie

Wyeth Laboratories Daalmeerstraat 24 2131 HC Hoofddorp The Netherlands

ABSTRACT 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 pg/ ethinylestradiol 30 1.19 (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.

INTRODUCTtON For various reasons, e.g. holidays, sports, examinations, women who use oral contraceptives might want to postpone their withdrawal bleeding. Despite the wide use of postponement of the withdrawal bleeding few articles have been published on this subject. We have investigated the efficacy of the postponement of the withdrawal bleeding for three weeks in 56 women who used gestodene 75 pgl ethinylestradiol 30 pg (Minulete). The acceptance of the seven-week cycle was evaluated. The results were compared with the results of an earlier study, with other oral contraceptives and with a comparable study protocol.

PATIENTS AND METHODS The

study

Submitted Accepted

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1992

was

an open,

multicenter

for publication for publication

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study

carried

out

in general

November 25, 1991 January 2, 1992

119

CONTRACEPTION practice. Sixty general practitioners throughout the Netherlands, who had already cooperated in an earlier study of Minulete, were invited to enroll patients. Each general practitioner could enroll two women. The inclusion criteria were that these women were healthy, aged between 18 and 40 and MinulePusers for the past six months without any pill-related problem. A total of 38 general practitioners included 55 volunteers in the study. These women took MinuleP for 42 consecutive days (2 pill strips without a seven-day tablet-free interval). On a diary card they filled in whether or not there was any spotting or breakthrough bleeding. Spotting was defined as scanty vaginal blood loss not requiring any hygienic measure and a breakthrough bleeding was defined as a vaginal blood loss which required hygienic measures. On the diary-card they also wrote down the time they took the pill, whatever complaints they experienced and whatever other medication they used. The women visited the general practitioner two times, one time before they started with the study medication and one time after they had finished both pill-strips. RESULTS A total of 55 women, who fulfilled the inclusion criteria entered the study. There was one dropout because of medical reasons not related to the study. The average age of the study population was 27, with a range from 18 to 40. During the first 21 days, 5 women (9%) experienced breakthrough bleeding or spotting. Surprisingly, from the 21st day till the 42nd day, only 8 women (15%) experienced breakthrough bleeding or spotting. We had expected a greater increase because this had been observed in earlier studies with other oral contraceptives.“* 21 Only two women experienced a breakthrough bleeding during the study period, both after the 21st day. During the whole study period (42 days),52 women (96%) experienced no breakthrough bleeding, 45 women (83%) experienced no spotting and 44 women (81%) experienced no spotting or breakthrough bleeding. Table I shows the calculated 95% confidence intervals for several days of the study period.

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CONTRACEPTION

Table

I

95%

Confidence

Percentage

Day of

non-bleeders

postponement

effects

were

for several

days of the study

Confidence lower

limit %

94.5% 91.3% 88.3% 85.6% 83.0% 80.5% 78.0% 75.7% 73.4% 71.2%

98.1% 96.3% 94.4% 92.6% 90.7% 88.9% 87.0% 85.2% 83.3% 81.5%

5 7 9 12 13 22 24 28 36 41

Side

intervals

period

intervals upper

limit %

100.0% 100.0% 100.0% 99.6% 98.4% 97.3% 96.0% 94.7% 93.2% 91.6%

infrequent:

A total of 8 women reported side effects. 4 women (7%) reported breasttenderness, 2 women (4%) reported nausea, 2 women (4%) reported abdominal bloating, 1 woman (2%) reported headache and 1 woman (2%) reported dysmenorrhea. 41 Women (76%) took the pill at night, IO women (18%) took the pill in the morning and of 3 women (6%) the time of the day was unknown. In view of the small number of women who took the pill in the morning, the occurrence of spotting and breakthrough bleeding and the occurrence of side effects could not be related to the time of pill-intake. Also the occurrence of spotting and breakthrough bleeding did not seem to be related to variation in the time of pill-intake. Three women used other medication during the study; two women used acetaminophen and one woman used ergotamine. This woman experienced a breakthrough bleeding after the use of ergotamine for migraine.

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CONTRACEPTION The question whether they were satisfied with the postponement of the withdrawal bleeding with Minulet@ was answered with: extremely satisfied by 36 women {66%), satisfied by 14 women (26%), moderately satisfied by 1 woman (2%) and 2 women (4%) answered that they were not satisfied at all. Of one person this score was unknown. The woman who was moderately satisfied had experienced a side effect and the two women who were not satisfied at all had experienced a breakthrough bleeding. A total of 92% of the women were thus either extremely satisfied or satisfied with this form of postponement of the withdrawal bleeding_

DISCUSSION Various studies G,~’ have shown that the combination gestodene 75 pgl ethinylestradiol 30 yg gives an excellent cycle control. In this study 85% of the women experienced no breakthrough bleeding or spotting from the 21st day till the 42nd day. In another postponement study (‘) with 105 women who used desogestrel 150 pug/ EE 30 Dg,75% of the women experienced no breakthrough bleeding or spotting from the 21st day till the 42nd day. In this study, 81% of the 54 women experienced no spotting or breakthrough bleeding during the seven-week cycle and 96% of the women exhibited no breakthrough bleeding (fig. 1 and 2). the cycle control for Hamerlynck et al. “I have studied levonorgestrel 150 pg/EE 30 pg, levonorgestrel 50, 75, 125 pg/EE 30, 40, 30 /rg and desogestrel 150 pg/EE 30 lug during a seven-week period. The inclusion criteria of our study and this study were identical and also the protocols were comparable. Of the 37 users of levonorgestrel 150 pg/EE 3Opg, 43% experienced no spotting or breakthrough bleeding and 76% experienced no breakthrough bleeding. Users of Ievonorgestrel 50, 75, 125 PgIEE 30, 40, 30 pug took after 21 days,levonorgestrel 125 pg/EE 30 pug for 20 days. Of the 34 women who followed this scheme, only 32% experienced no spotting or breakthrough bleeding and 53% experienced no breakthrough bleeding. Lastly, 52% of the 29 women who used desogestrel 150 pg/ EE 30 ,vg experienced no spotting or breakthrough bleeding and 72% experienced no breakthrough bleeding. These results are shown in fig. 3 and 4, together with the results of our study.

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CONTRACEPTION

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CONTRACEPTION



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CONTRACEPTION Comparing our results with the results of Hamerlynck, it can be concluded that gestodene 75 pg/ethinylestradiol 30 fig offered an excellent cycle control during this seven-week cycle. The average age of the women and other medication used were not specified in Hamerlynck’s study. In both studies, the weight of the women was not registered. It is unlikely, however, that the great differences, found for the cycle control, could be totally attributed to these factors. Product-linked properties (hormone dosage or hormone type) probably play an important role. In an earlier study, a better cycle control was observed for gestodene 75 pg/EE 30 pug than for levonorgestrel 150 pg/30 pg.r5’ Specific properties of the progestagen gestodene would seem to be the most probable explanation for the excellent cycle control observed in prior studies (with a four-week cycle) ‘3r4* 5’ and in this study for a seven-week cycle.

REFERENCES 1.

2.

3. 4.

5.

FEBRUARY

Hamerlynck J .V.T.H., Vollebregt J.A., Doornebos C.M., Muntendam P. ‘Postponement of Withdrawal Bleeding in Women Using Low-Dose Combined Oral Contraceptives. Contraception 1987;35,3: 199205. Voogd de W.S. Postponement of withdrawal bleeding with a monophasic oral contraceptive containing desogestrel and ethinylestradiol, Contraception 1991;44,2: 107-l 12. Hoppe G. Gestodene, An innovative Progestogen. Contraception 1988;37,5:493-501. Dusterberg B., Brill K. Clinical Experience with a LowDose Oral Contraceptive Containing Gestodene. Advances in Contraception 1991 ;G,Supplement: 37-50. Loudon N.B., Kirkman R.J., Dewsbury J.A. A double-blind comparison of the efficacy and acceptability of Femodene and Microgynon 30. Eur. J. Obstet. & Gynaecol. and Reprod. Biol. 991;34:257-266.

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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:...
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