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| Name | Class |
|---|---|
| Hamilton Academic Health Sciences Organization | OTHER |
| McMaster University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol) | Experimental | Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks |
|
| Placebo | Placebo Comparator | Continuous treatment with placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yaz | Drug | Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility outcome: treatment compliance | Treatment compliance - assessed via number and percentage of treatment pills taken | 12 weeks |
| Feasibility outcome: retention rates | Retention rates - number and percentage of people who remain in the study once randomized | 12 weeks |
| Feasibility outcome: recruitment rate (monthly) | Recruitment rate (monthly) - number of participants per month | 2 years |
| Feasibility outcome: recruitment capacity | Recruitment capacity - total number of participants randomized and enrolled | 2 years |
| Feasibility outcome: screening rates (monthly) | Screening rates (monthly) - number screened; number enrolled as a percentage of number screened | 2 years |
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Screening |
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Baseline |
| Feasibility outcome: duration of assessment process |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benicio N Frey, MD, MSc,PhD | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 3K7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37365881 | Derived | 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. |
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
| C035144 | drospirenone |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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|
| Placebo | Drug | Appearance, packaging, and labeling of placebo will be matched to their active counterpart. |
|
Duration of assessment process - mean in hours from start to finish for each visit |
| Week 4 |
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Week 8 |
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | 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) | 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) | 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) | Week 12 |
| Feasibility outcome: tolerability | Tolerability - assessed as percentage dropped out after randomization due to adverse events | Week 4 |
| Feasibility outcome: tolerability | Tolerability - assessed as percentage dropped out after randomization due to adverse events | Week 8 |
| Feasibility outcome: tolerability | Tolerability - assessed as percentage dropped out after randomization due to adverse events | 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 | 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 | Week 12 |
| Feasibility outcome: variance of the treatment effect | Variance of the treatment effect - standard deviation of above measure. | Week 12 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |