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Randomized Controlled Trial
. 2020 Aug 31;18(1):293.
doi: 10.1186/s12955-020-01544-4.

Effects of oral contraceptives on the quality of life of women with polycystic ovary syndrome: a crossover randomized controlled trial

Mina Amiri  1 , Fatemeh Nahidi  2 , Razieh Bidhendi Yarandi  1   3 , Davood Khalili  4 , Maryam Tohidi  4 , Fahimeh Ramezani Tehrani  5
Affiliations
Randomized Controlled Trial

Effects of oral contraceptives on the quality of life of women with polycystic ovary syndrome: a crossover randomized controlled trial

Mina Amiri et al. Health Qual Life Outcomes. .

Abstract

Background and objective: A limited number of studies have evaluated the effects of oral contraceptives (OCs) on the quality of life (QOL) of polycystic ovary syndrome (PCOS) patients. This study aimed to compare the effects of using OCs containing levonorgestrel (LNG) and those containing desogestrel (DSG), cyproterone acetate (CPA) or drospirenone (DRSP) for 6 months on the QOL with PCOS.

Methods: In this crossover randomized controlled 6-arm trial, 200 eligible patients with PCOS scheduled for OC therapy were randomly assigned to one of the 6 study arms. All 6 arms include two 6-month treatment periods, one period with OCs containing LNG, and the other with each of the 3 OCs containing DSG, CPA, or DRSP. Outcomes of interest were the total score of QOL and its domains, which were assessed using a specific and valid health-related quality of life questionnaire for PCOS, which is consisted of six domains, including psychosocial-emotional, self-image, fertility, sexual function, hirsutism, and obesity- menstrual disorders.

Results: Finally, a total of 88 patients were analyzed for this study. The results showed that use of OCs containing DSG, CPA, and DRSP for 3 months was not associated with significant differences in the total scores of QOL compared to those OCs containing LNG, whereas, after 6 months of treatment, patients treated with OCs containing CPA had more improvements in their total scores of QOL, in comparison to OCs containing LNG (P < 0.042). We found no significant differences in QoL domains, including psychosocial-emotional, self-image, fertility, sexual function, hirsutism, and obesity-menstrual disorders after 3-6 months of treatment with DSG, CPA, or DRSP, compared to LNG. The sequence and period effects were not significant in any of the analyses at 3 and 6 months of treatment. The carry-over effect was not significant for most outcomes assessed.

Conclusions: This crossover study demonstrated non-inferiority of OCs with newer generation progestins on different domains of QOL, in comparison with older compounds, although usage of products containing CPA was significantly associated with more improvement in total QOL of PCOS patients, compared to those containing LNG after 6-month of treatment.

Trial registration: IRCT201702071281N2 .

Keywords: Oral contraceptive (OC); Polycystic ovary syndrome (PCOS); Quality of life (QOL).

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Conflict of interest statement

Authors have no conflict of interest to declare.

Figures

Fig. 1
Fig. 1
Flow diagram of the study
Fig. 2
Fig. 2
a, b, c, d, e, f, g Graphical display of QOL and its domains based on the median and IQR in different timelines and periods (a: psychosocial–emotional domain; b: Self-image; c: fertility domain; d: sexual function; e: hirsutism; f: obesity– menstrual disorders; g: total QOL)
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