Premenstrual Dysphoric DisorderPhase 2NCT05098574
Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
A Phase 2 study testing Yaz in people with Premenstrual Dysphoric Disorder and Bipolar Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder, Bipolar Disorder
- What is being tested?
- Yaz
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2023to 11 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-45 years of age
- Diagnosis of BD (clinically euthymic) according to the DSM-5
- Diagnosis of PMDD according to the DSM-5
- Regular menstrual cycles
- No contraindication to use oral contraceptives
- Capable of consent for treatment
Who cannot join
- Smoking and over the age of 35
- Current or recent (last month) use of systemic estrogen or progesterone treatment
- Severe reactions to hormone treatment
- Pregnant or breastfeeding
- Current substance use disorder
- Oophorectomy or hysterectomy
- Current unstable medical conditions
- History of current or past breast cancer, pancreatitis, migraines or blood clotting disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder with Oral Contraceptives in Bipolar Disorder.
This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives.
Lay Summary:
Read more
This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians.
One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.
- Conditions
- Premenstrual Dysphoric Disorder, Bipolar Disorder
- Being tested
- Yaz, Placebo
- Keywords
- bipolar disorder, premenstrual dysphoric disorder
- Medical subject headings
- Premenstrual Dysphoric Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YazDrug
Also called 3mg drospirenone/ 0.02mg ethinyl estradiol
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
PlaceboDrug
Appearance, packaging, and labeling of placebo will be matched to their active counterpart.
| Study group | Role | What they receive |
|---|---|---|
| Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol) | Experimental | Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks Receives: Drug: Yaz |
| Placebo | Placebo comparator | Continuous treatment with placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome: treatment compliance
Treatment compliance - assessed via number and percentage of treatment pills taken
Measured: 12 weeks
Feasibility outcome: retention rates
Retention rates - number and percentage of people who remain in the study once randomized
Measured: 12 weeks
Feasibility outcome: recruitment rate (monthly)
Recruitment rate (monthly) - number of participants per month
Measured: 2 years
Feasibility outcome: recruitment capacity
Recruitment capacity - total number of participants randomized and enrolled
Measured: 2 years
Feasibility outcome: screening rates (monthly)
Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Measured: 2 years
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Measured: Screening
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Measured: Baseline
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Measured: Week 4
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Measured: Week 8
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Measured: Week 12
Feasibility outcome: safety of use of oral contraceptives in this population
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Measured: Week 4
Feasibility outcome: safety of use of oral contraceptives in this population
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Measured: Week 8
Feasibility outcome: safety of use of oral contraceptives in this population
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Measured: Week 12
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Measured: Week 4
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Measured: Week 8
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Measured: Week 12
Feasibility outcome: response rates
Response rates - response will be defined as 50% decrease from baseline symptom change from late luteal to follicular phase; remission will be defined as number and percentage of responders who no longer need DSM-5 criteria for PMDD
Measured: Week 12
Feasibility outcome: estimated treatment effect
Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase
Measured: Week 12
Feasibility outcome: variance of the treatment effect
Variance of the treatment effect - standard deviation of above measure.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start3 Feb 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual Dysphoric DisorderStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, McMaster University
- Responsible party
- Principal investigator, Benicio Frey, St. Joseph's Healthcare Hamilton
- Investigators
- Benicio N Frey, MD, MSc,PhD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098574
- Sponsor's protocol ID
- BDPMDD01
- Status last verified
- Sep 2024
- First submitted
- 14 Jul 2021
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma S, Song SJ. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2023 Jun 23;6(6):CD006586. doi: 10.1002/14651858.CD006586.pub5.
PubMed 37365881
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder with Oral Contraceptives in Bipolar Disorder.
- ClinicalTrials.gov ID
- NCT05098574
- Acronym / sponsor ID
- BDPMDD01
- Conditions
- Premenstrual Dysphoric Disorder, Bipolar Disorder
- Keywords
- bipolar disorder, premenstrual dysphoric disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, McMaster University
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 28 Oct 2021 (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.
This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives.
Lay Summary:
This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians.
One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol) | Experimental | Drug: YazContinuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboContinuous treatment with placebo for 12 weeks |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 16-45 years of age
- Diagnosis of BD (clinically euthymic) according to the DSM-5
- Diagnosis of PMDD according to the DSM-5
- Regular menstrual cycles
- No contraindication to use oral contraceptives
Key exclusion criteria (8 listed)
- Smoking and over the age of 35
- Current or recent (last month) use of systemic estrogen or progesterone treatment
- Severe reactions to hormone treatment
- Pregnant or breastfeeding
- Current substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YazAlso: 3mg drospirenone/ 0.02mg ethinyl estradiolContinuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks | Drug | Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol) |
| PlaceboAppearance, packaging, and labeling of placebo will be matched to their active counterpart. | Drug | Placebo |
Primary outcome
Feasibility outcome: treatment compliance
Time frame: 12 weeks
Treatment compliance - assessed via number and percentage of treatment pills taken
Feasibility outcome: retention rates
Time frame: 12 weeks
Retention rates - number and percentage of people who remain in the study once randomized
Feasibility outcome: recruitment rate (monthly)
Time frame: 2 years
Recruitment rate (monthly) - number of participants per month
Feasibility outcome: recruitment capacity
Time frame: 2 years
Recruitment capacity - total number of participants randomized and enrolled
Feasibility outcome: screening rates (monthly)
Time frame: 2 years
Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Feasibility outcome: duration of assessment process
Time frame: Screening
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Time frame: Baseline
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Time frame: Week 4
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Time frame: Week 8
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Time frame: Week 12
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: safety of use of oral contraceptives in this population
Time frame: Week 4
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Feasibility outcome: safety of use of oral contraceptives in this population
Time frame: Week 8
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Feasibility outcome: safety of use of oral contraceptives in this population
Time frame: Week 12
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Feasibility outcome: tolerability
Time frame: Week 4
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: tolerability
Time frame: Week 8
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: tolerability
Time frame: Week 12
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: response rates
Time frame: Week 12
Response rates - response will be defined as 50% decrease from baseline symptom change from late luteal to follicular phase; remission will be defined as number and percentage of responders who no longer need DSM-5 criteria for PMDD
Feasibility outcome: estimated treatment effect
Time frame: Week 12
Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase
Feasibility outcome: variance of the treatment effect
Time frame: Week 12
Variance of the treatment effect - standard deviation of above measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 37365881Ma S, Song SJ. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2023 Jun 23;6(6):CD006586. doi: 10.1002/14651858.CD006586.pub5.
- Individual participant dataSharing planned: No
Related trials for Premenstrual Dysphoric Disorder
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Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
Not yet recruitingObservational study
The SPARK-PMDD Study
Premenstrual Dysphoric Disorder, PMDD
RecruitingObservational study
To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
Premenstrual Dysphoric Disorder ( PMDD)
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. This study is not recruiting at the moment.
Benicio N Frey, MD, MSc,PhD principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yaz in people with Premenstrual Dysphoric Disorder and Bipolar Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 23 Sep 2024. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome: treatment compliance (time frame: 12 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098574, which also lists 1 linked publication.
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 23 Sep 2024.