Do PMDD patients have a different mid-luteal hormone balance than people without PMDD?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational case-control study compares serum progesterone and estradiol levels, and their ratio, seven days after ovulation (mid-luteal phase) between individuals with PMDD and healthy controls. Ovulation will be confirmed with a home LH test, and a single on-site blood draw in Lancaster will occur about seven days after the LH surge. The goal is to see if the progesterone-to-oestradiol ratio differs in PMDD, which could guide future research into the hormonal underpinnings of the disorder.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lancaster University
  Lancaster, Lancashire, United Kingdom Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Epigenetic markers linked to PMDD across the menstrual cycle

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• Investigating hormone effects on premenstrual dysphoric disorder

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• Samphire Guided Care for Wellbeing at Work

  This study tests a 12-week digital program with at-home neuromodulation to see if it helps women with menstrual or perimenopausal symptoms feel better at work and in daily life.

  Recruiting Samphire Group, Inc. · San Francisco, California · NCT07679074

• Online emotion-regulation cognitive behavioral therapy for premenstrual dysphoric disorder

  This test tries an 8-week therapist-guided online cognitive behavioral program focused on emotion regulation to reduce symptoms in women aged 18–45 with PMDD.

  Recruiting Uppsala University · Uppsala, Uppsala County · NCT06496139

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.