Premenstrual Dysphoric Disorder ( PMDD)NCT07686718
To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
An observational study of Premenstrual Dysphoric Disorder ( PMDD), run by Lancaster University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Dysphoric Disorder ( PMDD)
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2026to 1 Aug 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Lancaster University
Lancaster, Lancashire, LA1 4YW
Milli Raizazda, MBCHB Hons, +44 (0)1524 65201, m.raizada2@lancaster.ac.uk
Chris Gaffney, BSc (Hons.) MSc PhD SFHEA, +44 (0)1524 65201, c.gaffney@lancaster.ac.uk
About this study
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).
Read the 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.
- Conditions
- Premenstrual Dysphoric Disorder ( PMDD)
- Keywords
- PMDD, premenstrual dysphoric disorder, oestrogen, progesterone, ratios
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
blood level
progesterone
Measured: 5-7 days post ovulation
blood level
oestrogen
Measured: 5-7 days post ovulation
blood test
progesterone to oestrogen level
Measured: 5-7 days post ovulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start5 May 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Dysphoric Disorder ( PMDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milli Raizada, Lancaster University
- Investigators
- Chris Gaffney, BSc (Hons.) MSc PhD SFHEA, Study director, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686718
- Sponsor's protocol ID
- v1.9.9.3 20250922
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
- ClinicalTrials.gov ID
- NCT07686718
- Acronym / sponsor ID
- v1.9.9.3 20250922
- Conditions
- Premenstrual Dysphoric Disorder ( PMDD)
- Keywords
- PMDD, premenstrual dysphoric disorder, oestrogen, progesterone, ratios
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood level
Time frame: 5-7 days post ovulation
progesterone
blood level
Time frame: 5-7 days post ovulation
oestrogen
blood test
Time frame: 5-7 days post ovulation
progesterone to oestrogen level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Gaffney, BSc (Hons.) MSc PhD SFHEA study director
Lancaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Dysphoric Disorder ( PMDD), run by Lancaster University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milli Raizada, MBCHB Hons (+44 (0)1524 65201, m.raizada2@lancaster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood level (time frame: 5-7 days post ovulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.