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Evaluation of Luteal-phase Sex Hormone Profile and Ratio in Premenstrual Dysphoric Disorder (PMDD)

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Study Aim

This observational study aims to measure and compare the blood levels of progesterone and oestrogen, as well as their ratio, in individuals diagnosed with Premenstrual Dysphoric Disorder (PMDD).

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Mental Disorders+5

+ Depressive Disorder

+ Menstruation Disturbances

From 18 to 45 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2026
See protocol details

Summary

Principal SponsorLancaster University
Study ContactMilli Raizada, MBCHB HonsMore contacts
Last updated: July 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 5, 2026

Actual date on which the first participant was enrolled.

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.

Principal SponsorLancaster University
Study ContactMilli Raizada, MBCHB HonsMore contacts
Last updated: July 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive DisorderMenstruation DisturbancesPathologic ProcessesPremenstrual SyndromePathological Conditions, Signs and SymptomsMood DisordersPremenstrual Dysphoric Disorder

Criteria

8 inclusion criteria required to participate
Provide written informed consent

Attend a single in person on site in Lancaster mid luteal blood test sample appointment (approx 7 days post LH surge)

Have sufficient English language skills to understand the patient information

Aged 18-45 years old (adults but less than the typical perimenopausal age so there is not added bias/variable)

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12 exclusion criteria prevent from participating
Needle phobic so that venepuncture is intolerable

Other endocrine disorders e.g. uncontrolled thyroid disease, high prolactin, cushing's syndrome, polycystic ovarian syndrome)

Premature ovarian insufficiency

Irregular menstrual cycles (outside the 21-35 day window)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Lancaster University

Lancaster, United KingdomOpen Lancaster University in Google Maps
Recruiting
One Study Center