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To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.

2026年6月29日更新者：Milli Raizada、Lancaster University

The aim of this project is to compare the ovarian hormone levels 7 days after ovulation and progesterone:oestradiol ratios between PMDD individuals and a control cohort (case control study).

研究概览

地位

招聘中

条件

经前期烦躁症 (PMDD)

详细说明

Premenstrual dysphoric disorder (PMDD) is a severe cyclical disorder characterised by affective, cognitive and physical symptoms occurring during the luteal phase of the menstrual cycle and resolving shortly after the onset of menstruation. Although circulating ovarian hormone concentrations are generally considered to be within physiological reference ranges, increasing evidence suggests that altered sensitivity to normal hormonal fluctuations, rather than absolute hormone concentrations alone, may contribute to symptom development.

The progesterone-to-oestradiol ratio has been proposed as a potential biological marker of luteal hormonal balance; however, this has not been systematically evaluated in individuals with PMDD compared with asymptomatic controls.

This observational case-control study will compare serum progesterone concentrations, serum oestradiol concentrations, and the progesterone-to-oestradiol ratio during the mid-luteal phase between participants with PMDD and healthy controls. Hormone measurements will be obtained following confirmation of ovulation using a urinary luteinising hormone (LH) surge, with blood sampling performed approximately seven days after the LH surge to standardise assessment within the mid-luteal phase.

The findings will provide preliminary evidence regarding whether alterations in the progesterone-to-oestradiol ratio are associated with PMDD and may inform future mechanistic studies investigating the endocrine basis of the disorder.

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Milli Raizada, MBCHB Hons
电话号码：+44 (0)1524 65201
邮箱：m.raizada2@lancaster.ac.uk

学习地点

英国
- Lancashire
  - Lancaster、Lancashire、英国、LA1 4YW
    - 招聘中
    - Lancaster University
    - 接触：
      
      Milli Raizazda, MBCHB Hons
      
      电话号码：+44 (0)1524 65201
      
      邮箱：m.raizada2@lancaster.ac.uk
    - 接触：
      
      Chris Gaffney, BSc (Hons.) MSc PhD SFHEA
      
      电话号码：+44 (0)1524 65201
      
      邮箱：c.gaffney@lancaster.ac.uk
    - 首席研究员：
      
      milli raizada, MBCHB Hons
    - 副研究员：
      
      chris gaffney, BSc (Hons.) MSc PhD SFHEA

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

adults of reproductive age who experience menstrual cycles and have a diagnosis of, or symptoms consistent with, Premenstrual Dysphoric Disorder (PMDD) or a control population

描述

Inclusion criteria

Aged 18-45 years old (adults but less than the typical perimenopausal age so there is not added bias/variable)
Regular menstrual cycles (21-35 days for the last 3 months)
Willing and able to complete a questionnaire (no new clinical diagnosis given)
Use home urine LH test strips to detect ovulation
Attend a single in person on site in Lancaster mid luteal blood test sample appointment (approx 7 days post LH surge)
Provide written informed consent
Have sufficient English language skills to understand the patient information
Be either in Group 1 or group 2 Group 1 (PMDD group ie case group) - self reported prior diagnosis of PMDD made by a healthcare professional (GP, psychiatrist, gynaecologist) Group 2 (Control group ie comparison group) - no prior diagnosis of PMDD made by a healthcare professional and no history of clinically significant premenstrual mood symptoms on screening

Exclusion criteria

Current use or use in the last 3 months of hormonal contraception such as the combined oral contraceptive pill, the progestogen only pill, the implant, the injection, hormonal coil (Mirena, Kyleena) or patch/ring.
Current use or use in the last 3 months of any hormone replacement therapy (e.g. combined oestrogen and progesterone, oestrogen and Mirena coil combination, oestrogen alone if had a hysterectomy, or progesterone alone) or GnRH analogues use
On a selective serotonin reuptake inhibitor (SSRI) with a recent initiation or dose change within the last 3 months
Pregnant, breastfeeding or within 3 months post partum
Irregular menstrual cycles (outside the 21-35 day window)
Surgical menopause
Premature ovarian insufficiency
Other endocrine disorders e.g. uncontrolled thyroid disease, high prolactin, cushing's syndrome, polycystic ovarian syndrome)
Regular systemic steroid use or use of other medications known to affect sex hormone within the last 3 months
Severe mental health issues that impair consent or participation
Needle phobic so that venepuncture is intolerable
The use of the emergency contraceptive pill either 3 months prior to the study or during the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
control group oestrogen and progesterone levels and ratios 5-7 days post ovulation
PMDD group oestrogen and progesterone levels and ratios 5-7 days post ovulation

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
blood level 大体时间：5-7 days post ovulation	progesterone	5-7 days post ovulation
blood level 大体时间：5-7 days post ovulation	oestrogen	5-7 days post ovulation
blood test 大体时间：5-7 days post ovulation	progesterone to oestrogen level	5-7 days post ovulation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lancaster University

调查人员

研究主任：Chris Gaffney, BSc (Hons.) MSc PhD SFHEA、Lancaster University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月5日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日