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

NCT07686718 | Recruiting DMC

• 1 other identifier: v1.9.9.3 20250922
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Premenstrual Dysphoric Disorder ( PMDD)

Keywords

PMDD; premenstrual dysphoric disorder; oestrogen; progesterone; ratios

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with PMDD or women without PMDD
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lancaster University: lead

Study Sites (1)

Lancaster University

Lancaster, Lancashire, LA1 4YW, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum to test for oestrogen and progesterone

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Chris Gaffney, BSc (Hons.) MSc PhD SFHEA

  Lancaster University

  STUDY DIRECTOR

Central Study Contacts

Milli Raizada, MBCHB Hons

CONTACT

+44 (0)1524 65201; m.raizada2@lancaster.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 7, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

GB (1)