Cargando…

Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder

BACKGROUND: Up to 80% of reproductive-aged women experience premenstrual symptoms. Premenstrual Dysphoric Disorder (PMDD) is a severe form, affecting 2-5% of women. Combined oral contraceptive pills (COCPs) are used in the treatment of PMDD. Clinical practice suggests that a newer COCP containing no...

Descripción completa

Detalles Bibliográficos
Autores principales: Robertson, Emily, Thew, Caroline, Thomas, Natalie, Karimi, Leila, Kulkarni, Jayashri
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498579/
https://www.ncbi.nlm.nih.gov/pubmed/34630323
http://dx.doi.org/10.3389/fendo.2021.704488
_version_ 1784580193763983360
author Robertson, Emily
Thew, Caroline
Thomas, Natalie
Karimi, Leila
Kulkarni, Jayashri
author_facet Robertson, Emily
Thew, Caroline
Thomas, Natalie
Karimi, Leila
Kulkarni, Jayashri
author_sort Robertson, Emily
collection PubMed
description BACKGROUND: Up to 80% of reproductive-aged women experience premenstrual symptoms. Premenstrual Dysphoric Disorder (PMDD) is a severe form, affecting 2-5% of women. Combined oral contraceptive pills (COCPs) are used in the treatment of PMDD. Clinical practice suggests that a newer COCP containing nomegestrol acetate (2.5mg) and 17-beta estradiol (1.5mg), may be a suitable treatment for mood symptoms in PMDD. MATERIALS AND METHODS: This was a clinical follow-up feasibility study of women who had attended the Monash Alfred Psychiatry research centre, Women’s Mental Health Clinic, with a diagnosis of PMDD. 67% of the sample also had concurrent cPTSD, 29% co-morbid anxiety, and 20% depression. They were recommended treatment with nomegestrol acetate/17-beta estradiol. Eligible women were contacted by telephone to answer a questionnaire to assess women’s subjective response to nomegestrol acetate/17-beta estradiol, acceptability and the Depression, Anxiety and Stress Scale-21 (DASS-21) after being recommended nomegestrol acetate/17-beta estradiol. The paired-sample t-test was used to determine if there were any statistically significant differences in the DASS-21 scores over the study observation period (before and after taking nomegestrol acetate/17-beta estradiol). RESULTS: 35 (74.5%) women reported a subjective positive mood response to nomegestrol acetate/17-beta estradiol, 31 (63.3%) adhered to the medication, and only 10 (20.4%) women reported side effects as the main reason for discontinuing nomegestrol acetate/17-beta estradiol. There were statistically significant reductions (p<0.05) in the overall DASS-21 scores from before women commenced nomegestrol acetate/17-beta estradiol and after commencement of treatment. CONCLUSIONS: This preliminary study supports the acceptability and effectiveness of nomegestrol acetate/17-beta estradiol as a treatment for mood symptoms in PMDD. Further research, particularly a randomized controlled trial, is required to elucidate the effect of nomegestrol acetate/17-beta estradiol treatment on mood in PMDD.
format Online
Article
Text
id pubmed-8498579
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-84985792021-10-09 Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder Robertson, Emily Thew, Caroline Thomas, Natalie Karimi, Leila Kulkarni, Jayashri Front Endocrinol (Lausanne) Endocrinology BACKGROUND: Up to 80% of reproductive-aged women experience premenstrual symptoms. Premenstrual Dysphoric Disorder (PMDD) is a severe form, affecting 2-5% of women. Combined oral contraceptive pills (COCPs) are used in the treatment of PMDD. Clinical practice suggests that a newer COCP containing nomegestrol acetate (2.5mg) and 17-beta estradiol (1.5mg), may be a suitable treatment for mood symptoms in PMDD. MATERIALS AND METHODS: This was a clinical follow-up feasibility study of women who had attended the Monash Alfred Psychiatry research centre, Women’s Mental Health Clinic, with a diagnosis of PMDD. 67% of the sample also had concurrent cPTSD, 29% co-morbid anxiety, and 20% depression. They were recommended treatment with nomegestrol acetate/17-beta estradiol. Eligible women were contacted by telephone to answer a questionnaire to assess women’s subjective response to nomegestrol acetate/17-beta estradiol, acceptability and the Depression, Anxiety and Stress Scale-21 (DASS-21) after being recommended nomegestrol acetate/17-beta estradiol. The paired-sample t-test was used to determine if there were any statistically significant differences in the DASS-21 scores over the study observation period (before and after taking nomegestrol acetate/17-beta estradiol). RESULTS: 35 (74.5%) women reported a subjective positive mood response to nomegestrol acetate/17-beta estradiol, 31 (63.3%) adhered to the medication, and only 10 (20.4%) women reported side effects as the main reason for discontinuing nomegestrol acetate/17-beta estradiol. There were statistically significant reductions (p<0.05) in the overall DASS-21 scores from before women commenced nomegestrol acetate/17-beta estradiol and after commencement of treatment. CONCLUSIONS: This preliminary study supports the acceptability and effectiveness of nomegestrol acetate/17-beta estradiol as a treatment for mood symptoms in PMDD. Further research, particularly a randomized controlled trial, is required to elucidate the effect of nomegestrol acetate/17-beta estradiol treatment on mood in PMDD. Frontiers Media S.A. 2021-09-24 /pmc/articles/PMC8498579/ /pubmed/34630323 http://dx.doi.org/10.3389/fendo.2021.704488 Text en Copyright © 2021 Robertson, Thew, Thomas, Karimi and Kulkarni https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Endocrinology
Robertson, Emily
Thew, Caroline
Thomas, Natalie
Karimi, Leila
Kulkarni, Jayashri
Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder
title Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder
title_full Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder
title_fullStr Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder
title_full_unstemmed Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder
title_short Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder
title_sort pilot data on the feasibility and clinical outcomes of a nomegestrol acetate oral contraceptive pill in women with premenstrual dysphoric disorder
topic Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498579/
https://www.ncbi.nlm.nih.gov/pubmed/34630323
http://dx.doi.org/10.3389/fendo.2021.704488
work_keys_str_mv AT robertsonemily pilotdataonthefeasibilityandclinicaloutcomesofanomegestrolacetateoralcontraceptivepillinwomenwithpremenstrualdysphoricdisorder
AT thewcaroline pilotdataonthefeasibilityandclinicaloutcomesofanomegestrolacetateoralcontraceptivepillinwomenwithpremenstrualdysphoricdisorder
AT thomasnatalie pilotdataonthefeasibilityandclinicaloutcomesofanomegestrolacetateoralcontraceptivepillinwomenwithpremenstrualdysphoricdisorder
AT karimileila pilotdataonthefeasibilityandclinicaloutcomesofanomegestrolacetateoralcontraceptivepillinwomenwithpremenstrualdysphoricdisorder
AT kulkarnijayashri pilotdataonthefeasibilityandclinicaloutcomesofanomegestrolacetateoralcontraceptivepillinwomenwithpremenstrualdysphoricdisorder