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

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).

Study Overview

• Status: Recruiting
• Conditions: Premenstrual Dysphoric Disorder ( PMDD)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Milli Raizada, MBCHB Hons; Phone Number: +44 (0)1524 65201; Email: m.raizada2@lancaster.ac.uk

Study Locations

• United Kingdom
  • Lancashire
    • Lancaster, Lancashire, United Kingdom, LA1 4YW
      • Recruiting
      • Lancaster University
      • Contact: Milli Raizazda, MBCHB Hons; Phone Number: +44 (0)1524 65201; Email: m.raizada2@lancaster.ac.uk
      • Contact: Chris Gaffney, BSc (Hons.) MSc PhD SFHEA; Phone Number: +44 (0)1524 65201; Email: c.gaffney@lancaster.ac.uk
      • Principal Investigator: milli raizada, MBCHB Hons
      • Sub-Investigator: chris gaffney, BSc (Hons.) MSc PhD SFHEA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood level	progesterone	5-7 days post ovulation
blood level	oestrogen	5-7 days post ovulation
blood test	progesterone to oestrogen level	5-7 days post ovulation

Collaborators and Investigators

• Sponsor: Lancaster University
• Investigators: Study Director: Chris Gaffney, BSc (Hons.) MSc PhD SFHEA, Lancaster University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: progesterone; PMDD; premenstrual dysphoric disorder; oestrogen; ratios
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Menstruation Disturbances; Premenstrual Syndrome; Pathological Conditions, Signs and Symptoms; Premenstrual Dysphoric Disorder
• Other Study ID Numbers: v1.9.9.3 20250922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be shared publicly because the study involves sensitive health information and there is a risk that participants could be identifiable despite de-identification procedures. Data will be stored and managed in accordance with ethical approval, data protection regulations, and participant consent. Aggregate, anonymised results will be disseminated through publications, presentations, and other scholarly outputs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No