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| ID | Type | Description | Link |
|---|---|---|---|
| LXP-MD-123 (Forest Pharm) | Other Identifier | Forest Research Institute | |
| LXP-MD-123 | Other Identifier | Forest Research Institute |
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Enrollment too slow.
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.
The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| escitalopram | Experimental | Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. |
|
| placebo | Placebo Comparator | Placebo tablets matched to drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Daily Symptom Rating Score. | A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408. | baseline and 5 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan Disability Scale (SDS) | Throughout study | |
| Patient Global Evaluation of Improvement (PGE) | Throughout treatment | |
| Subject Satisfaction Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Freeman | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept OB/GYN, Mudd Professorship Suite | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17174829 | Background | Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402. doi: 10.1016/j.jpag.2006.06.015. |
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During the screen period of 2 menstrual cycles, subjects rated daily symptom diaries to indicate the presence and severity of premenstrual symptoms. A total premenstrual score >80 in each cycle was required for randomization.
The recruitment period was from 01/25/08 to 07/07/09. The study was conducted in an academic research unit. 54 females signed consent for the study at visit 1. 43 were ineligible during the screen period and 11 were randomized to double-blind treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. |
| FG001 | Sugar Pill | Placebo tablets matched to drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject Daily Symptom Rating Score. | A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408. | Posted | Mean | Standard Deviation | units on a scale | baseline and 5 months. |
|
3 treatment months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram | Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Freeman, Principal Investigator | University of Pennsylvania | 215 662-3329 | freemane@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
|
| placebo | Other | Placebo tablets matched to drug |
|
| Study endpoint |
| Sugar Pill |
Placebo tablets matched to drug. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Sheehan Disability Scale (SDS) | Data not analyzed due to only 11 subjects. | Posted | Throughout study |
|
|
| Secondary | Patient Global Evaluation of Improvement (PGE) | Not analyzed due to small number of subjects | Posted | Throughout treatment |
|
|
| Secondary | Subject Satisfaction Questionnaire | Not analyzed due to small number of subjects. | Posted | Study endpoint |
|
|
| 0 |
| 7 |
| 5 |
| 7 |
| EG001 | Sugar Pill | Placebo tablets matched to drug. | 0 | 4 | 0 | 4 |
| headache | Nervous system disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| breast tenderness | Reproductive system and breast disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| other | General disorders | Systematic Assessment |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |