scholarly journals 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 (Preprint)

2017 ◽  
Author(s):  
Mina Amiri ◽  
Fatemeh Nahidi ◽  
Davood Khalili ◽  
Razieh Bidhendi-Yarandi ◽  
Fahimeh Ramezani Tehrani
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Oral Contraceptives ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Metabolic Parameters ◽  
Ovary Syndrome ◽  
Randomized Controlled

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. CLINICALTRIAL 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)

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

2020 ◽  
Author(s):  
Mina Amiri ◽  
Fatemeh Nahidi ◽  
Razieh Bidhendi-Yarandi ◽  
Davood Khalili ◽  
Maryam Tohidi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Polycystic Ovary Syndrome ◽  
Oral Contraceptives ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Period Effects ◽  
Carry Over

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. 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.

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

2020 ◽  
Author(s):  
Mina Amiri ◽  
Fatemeh Nahidi ◽  
Razieh Bidhendi-Yarandi ◽  
Davood Khalili ◽  
Maryam Tohidi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Polycystic Ovary Syndrome ◽  
Sexual Function ◽  
Oral Contraceptives ◽  
Polycystic Ovary ◽  
Menstrual Disorders ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Self Image

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. Clinical Trial Registration Number: IRCT201702071281N2.

Sign in / Sign up

Export Citation Format

Share Document