Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives

doi:10.1016/j.contraception.2006.03.022

Contraception

Volume 74, Issue 3, September 2006, Pages 220-223

https://doi.org/10.1016/j.contraception.2006.03.022 Get rights and content

Abstract

Objective

The objective of this study was to compare cycle control, tolerability and sexual well-being with the use of three hormonal contraceptives.

Methods

In this prospective randomized study, the effects of two combined oral contraceptives [20 μg of ethinylestradiol (EE)/100 μg of levonorgestrel and 15 μg of EE/60 μg of gestodene] were compared with those of the vaginal ring (15 μg of EE/120 μg of etonogestrel). One-year data from 280 women were obtained. We investigated the pattern of menstrual cycle and the incidence of weight gain, nausea, headache, breast tenderness, irritability, depression and vaginal dryness. Moreover, desire and sexual satisfaction were evaluated. Finally, the cumulative rate of discontinuation in the three groups was estimated.

Conclusion

The analysis of adverse events revealed two crucial points for acceptability, compliance and continuation: poor cycle control and disturbance of sexual intercourse due to vaginal dryness and loss of desire.

Introduction

Biological and psychological changes are linked to hormonal contraception, and their eventual adverse effects can play an important role in determining acceptability. The development of new combined oral contraceptives (COCs) has been directed toward regimens containing the lowest suitable dose of estrogen and using more selective progestogens in order to minimize steroid-associated unfavorable effects [1], [2]. However, the reduction of the ethinylestradiol (EE) dose below 20 μg/day adversely affects cycle control. In fact, during the first cycle, the low dose (20 μg/day) was associated with irregular bleeding in almost 20% of users, whereas the incidence was notably higher (almost 35%) with the very low dose (15 μg/day) [3]. In addition, all COCs rely on daily pill intake and this result in hormonal fluctuations that may also account for poor compliance. Because of such disadvantages, other approaches have been investigated, which led to the development of a vaginal ring to administer hormonal contraceptives (15 μg of EE/120 μg of etonogestrel). In contrast to oral contraceptives, in recent studies, only 6–12% of vaginal ring users experienced irregular bleeding after 3 months [4], [5]. Cycle control is a crucial element that affects contraceptive compliance, but other side effects can exert a leading role in acceptability and compliance. The most common treatment-related adverse effects are headache, nausea, breast tenderness, weight gain, irritability and depression [6], [7], [8], [9]. Although some investigations reported vaginal dryness and loss of libido with COCs, recent observational studies reported that vaginal ring users revealed positive changes in vaginal lubrication and sexual satisfaction [5], [6], [10]. The aim of the present study was to compare the effects of three hormonal contraceptive formulations on acceptability regarding cycle control, side effects and sexual well-being.

Section snippets

Materials and methods

This prospective randomized study was carried out between December 2003 and June 2005. Overall, women with regular menstrual cycles who were sexually active and in need of contraception were recruited after signing an informed consent form. The protocol of the present investigation conformed to the recommendations of the Helsinki Declaration (Amendment 1989) and the European Guidelines (1990). Only women who were with the same partner throughout the study period were randomized to one of three

Results

A total of 280 women started treatment with hormonal contraception according to a randomization list. Demographic and baseline characteristics were similar between the treatment groups. There were 18 (19.1%), 13 (14.1%) and 21 (22.5%) smokers (<12 cigarettes/day) in the L,VL and VR groups, respectively. The length of the menstrual cycle and the menstrual flow were normal at screening in all cases (Table 1). Previously, 84.1%, 81.6% and 79.8% of the participants in each group, respectively, had

Discussion

Adverse events represent the main factors in determining acceptability and compliance with any contraceptive method. In the present study, we focused our attention on the physical and psychological effects of two oral contraceptives as compared with the vaginal ring. Although weight gain is commonly perceived as a disadvantage of oral contraception, in the current investigation, no significant weight change was detected, similar to other clinical trials [6], [9], [10]. In this analysis,

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A spin-off study of a randomized, open-label trial. Fifty-nine healthy women were allocated to groups that engaged in the continuous use of EV+dienogest (DNG), EE+DNG, or DNG only for 9 weeks. We measured changes in adrenal steroids, CBG, and the free cortisol index (FCI).
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Citation Excerpt :
In COC-15 μg EE/60 μg of Gestodene, early withdrawal bleeding, late withdrawal bleeding and irregular bleeding were more common than other COC groups. Therefore, it was concluded that the vaginal ring produced reasonable cycle control, avoided hormonal fluctuations, and showed higher acceptability than COC groups [32]. Alfaiate et al. investigated the local tolerance and efficacy of spermicide benzalkonium chloride (BKC), myristalkonium chloride (MKC) and compared it with nonoxynol-9 (N-9), which is the most prevalent spermicide in vaginal contraceptives.
Family planning enables society to prevent unintended pregnancies and helps in attaining desired spacing between the pregnancies. It is done with the use of contraceptive methods and infertility treatments. The use of contraceptives serves to ease maternal ill-health and reduce pregnancy-related deaths and helps to decrease the number of unsafe abortions and HIV transmission from mothers to newborns. The most popular contraception method is a daily dose of combined oral contraceptives pills. However, poor compliance and various adverse effects are common problems of oral contraceptives that considerably reduce their long-term use. Thus, several non-oral contraceptive options have been developed for better compliance, reduced side effects and improved therapeutic efficacy. This review presented the non-oral contraceptive formulations given by different routes such as transdermal, nasal, subcutaneous, intramuscular, intrauterine and vaginal routes. These formulations delivering contraceptives, mainly through devices, include transdermal patches and microneedles, nasal sprays, intrauterine devices and intrauterine systems, vaginal rings, contraceptive implants and contraceptive injections, which are unique in their specific advantages and drawbacks.
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Following screening, 151 publications describing 123 studies with 34,740 ring users and 5,694 hypothetical users were included. Twenty-five studies were excluded from meta-analysis due to reporting product continuation without also reporting general acceptability [10, 28−47], reporting continuous rather than labelled categorical or dichotomous outcomes [48] and reporting preference data only [49, 50] (Fig. 1). Some secondary manuscripts of the included studies assessed acceptability across ring groups with different characteristics (e.g. active and placebo rings) and were not included in meta-analysis.
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Original research articleComparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives

Abstract

Objective

Methods

Conclusion

Introduction

Section snippets

Materials and methods

Results

Discussion

Am J Obstet Gynecol

Am J Obstet Gynecol

Contraception

Clin Ther

Contraception

Contraception

Original research article
Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives