Elsevier

Contraception

Volume 71, Issue 1, January 2005, Pages 1-7
Contraception

Original research article
A comparative study of monophasic oral contraceptives containing either drospirenone 3 mg or levonorgestrel 150 μg on premenstrual symptoms

https://doi.org/10.1016/j.contraception.2004.07.010Get rights and content

Abstract

This open-label randomized study compared the effects of two combined oral contraceptives (OCs) containing 3 mg drospirenone (DRSP)/30 μg ethinyl estradiol (EE) with 150 μg levonorgestrel (LNG)/30 μg EE on the prevalence and changes from baseline of premenstrual symptoms after six cycles. The symptoms were measured using the Women's Health Assessment Questionnaire. Subjects receiving DRSP/EE had fewer prevalence of premenstrual symptoms than those receiving LNG/EE after six cycles. A significantly lower score of negative affect category in the premenstrual phase was demonstrated in those receiving DRSP/EE more than LNG/EE. The DRSP/EE group showed a greater improvement of mean scores from baseline in the premenstrual phase compared with those who received LNG/EE on negative affect as seen in the items on anxiety, irritability, feeling sad or blue and weight gain in the category of water retention. In conclusion, OCs containing DRSP have beneficial effects in reducing the prevalence of premenstrual symptoms especially the symptoms of negative affect and weight gain, particularly when compared to LNG/EE. Hence, it should be recommended for women who are susceptible to these adverse symptoms.

Introduction

About 20–90% of women experience premenstrual symptoms and 2–15% of them have severe symptoms [1], [2], [3], [4]. According to Moos [5], [6], premenstrual symptoms comprise eight “categories,” negative affect, water retention, impaired concentration, pain, behavioral change, autonomic reaction, arousal and control. Some women who used oral contraceptives (OCs) to prevent pregnancy found these symptoms to be much milder [5], [7]; on the other hand, some symptoms such as water retention and mood swings might become worse. The latter experiences have been important reasons for discontinuation of OCs [8], [9], [10], [11], [12]. Each progestogen has varying androgenic, estrogenic and antiestrogenic activities, which may cause unwanted adverse effects that could contribute to premenstrual symptoms. Backstorm et al. [13] showed that monophasic desogestrel provoked less change in mood parameters than monophasic and triphasic levonorgestrel (LNG).

Recently, an OC containing drospirenone 3 mg (DRSP) in combination with ethinyl estradiol 30 μg (EE) was developed. Drospirenone is different from other progestogens in that it is an analogue of the aldosterone antagonist, spironolactone [14]. Spironolactone appears to be an effective therapy for the negative mood change and somatic symptoms of premenstrual symptoms [15], [16], [17]. The pharmacologic profile of drospirenone is more closely related to progesterone than other synthetic progestogens in terms of antimineralocorticoid and antiandrogenic activities [14], [18], [19], [20]. Studies of OCs containing DRSP on premenstrual symptoms showed benefits on premenstrual symptoms, that is, decreased negative affect and water retention symptoms and increased general well-being [2], [21], [22], [23], [24]. However, these effects did not reach the level of statistical significance when compared to the placebo group: patients who suffered from premenstrual dysphoric disorder after three cycles of treatment [25].

There are few trials that compare OCs which have antimineralocorticoid and antiandrogenic properties (i.e., OC containing DRSP) with other pills which do not have these properties regarding premenstrual symptoms. In this study, we chose an OC containing LNG which is widely used in Thailand to compare to an OC containing DRSP regarding premenstrual symptoms.

The primary objective of this study was to compare the prevalence of premenstrual symptoms at six cycles in those who used EE 30 μg and DRSP 3 mg (DRSP/EE) with EE 30 μg and levonorgestrel 150 μg (LNG/EE) as a contraceptive method.

The secondary objective was to compare the effect of both preparations on premenstrual symptoms at six cycles after treatment.

Section snippets

Study design and population

This study was an open-label, randomized, comparative study performed at the family planning clinic of King Chulalongkorn Memorial Hospital, Bangkok, Thailand, from February to September 2003. The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Chulalongkorn University.

One-hundred and four women who were willing to take oral OC pills for contraception were randomly assigned to two groups: one used the preparation of EE 30 μg and DRSP 3 mg, and the other used the

Results

The demographic data were not significantly different between the two groups as shown in Table 2. A total of 104 subjects were allocated to either treatment protocol, 99 (95.2%) of them completed the study and 5 subjects withdrew prematurely; three cases in the LNG/EE group: one was lost to follow up, one switched to an implantable contraceptive and the other withdrew due to adverse side effects (nausea, vomiting and dizziness); two cases in the DRSP/EE group lost to follow-up.

The prevalence of

Discussion

The prevalence of premenstrual symptoms at baseline of both groups was about 60%, this is in corroboration with previous studies [1], [2], [3], [4]. This study demonstrated that DRSP/EE OC reduced the prevalence of premenstrual symptoms by half whereas LNG/EE OC did not alter the prevalence of premenstrual symptoms at cycle 6. Foidart et al. [27] studied the incidence of premenstrual symptoms by comparing DRSP/EE with an OC containing desogestrel for 26 cycles and reported that the incidence of

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