Comparing the Effects of Oral Contraceptives Containing Levonorgestrel With Products Containing Antiandrogenic Progestins on Clinical, Hormonal, and Metabolic Parameters and Quality of Life in Women With Polycystic Ovary Syndrome: Crossover Randomized Controlled Trial Protocol

Mina Amiri; Fatemeh Nahidi; Davood Khalili; Razieh Bidhendi-Yarandi; Fahimeh Ramezani Tehrani

doi:10.2196/resprot.8631

Comparing the Effects of Oral Contraceptives Containing Levonorgestrel With Products Containing Antiandrogenic Progestins on Clinical, Hormonal, and Metabolic Parameters and Quality of Life in Women With Polycystic Ovary Syndrome: Crossover Randomized Controlled Trial Protocol

JMIR Res Protoc. 2017 Sep 29;6(9):e191. doi: 10.2196/resprot.8631.

Authors

Mina Amiri^{1

2}, Fatemeh Nahidi¹, Davood Khalili³, Razieh Bidhendi-Yarandi^{2

4}, Fahimeh Ramezani Tehrani²

Affiliations

¹ Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran.
² Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran.
³ Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Science, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran.
⁴ Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Islamic Republic Of Iran.

Abstract

Background: Oral contraceptives (OCs) have been used as a first-line option for medical treatment in women with polycystic ovary syndrome (PCOS). Despite theoretical superiority of products containing antiandrogenic progestins compared to OCs containing levonorgestrel (LNG), the clinical advantage of these compounds remains unclear.

Objective: The aim of this study was to compare the effects of OCs containing LNG with products containing antiandrogenic progestins including cyproterone acetate, drospirenone, and desogestrel on clinical, hormonal, and metabolic parameters and quality of life in women with PCOS.

Methods: We conducted a 6-arm crossover randomized controlled trial with each arm including OCs containing LNG and one of those 3 OCs containing antiandrogenic progestins. The anthropometric and clinical manifestations and hormonal and biochemical parameters of participants were assessed at 6 time points including baseline, after washout period, and 3 and 6 months after intervention.

Results: The study is ongoing and follow-up of recruited women will continue until 2018.

Conclusions: This study will provide scientific evidence on comparability of OCs with the various progesterones that will assist in decision making taking into account cost effectiveness.

Trial registration: Iranian Registry of Clinical Trials IRCT201702071281N2; http://www.irct.ir/searchresult.php? keyword=&id=1281&number=2&prt=12869&total=10&m=1 (Archived by WebCite at http://www.webcitation.org/6tSP8FNWo).

Keywords: oral contraceptives; polycystic ovary syndrome; progestin; randomized controlled trial.

©Mina Amiri, Fatemeh Nahidi, Davood Khalili, Razieh Bidhendi-Yarandi, Fahimeh Ramezani Tehrani. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.09.2017.