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The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (PD) patients.
It is well established that excess prostaglandin production in primary dysmenorrhea (PD) leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients with non-steroid anti-inflammatory drugs (NSAIDs) being the most effective with the overall success rate of more than 75%. Oral contraceptive pills (OCP) are also an established treatment for PD with the success rate of 70%. Lately, OCP's have been used continuously in patients with endometriosis and had better pain control than traditional administration of OCP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group (CCOCP) | Experimental | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles |
|
| control group (traditional OCP) | Active Comparator | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCOCP | Drug | (CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) Score | Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain. | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Legro, M.D. | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Gradiska General Hospital | Strossmayerova 17 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37523477 | Derived | Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4. | |
| 22617578 | Derived | Dmitrovic R, Kunselman AR, Legro RS. Continuous compared with cyclic oral contraceptives for the treatment of primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1143-50. doi: 10.1097/AOG.0b013e318257217a. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group (CCOCP) | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles |
| FG001 | Control Group (Traditional OCP) | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group (CCOCP) | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles |
| BG001 | Control Group (Traditional OCP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Visual Analog Scale (VAS) Score | Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 months |
|
6 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 | Study Group (CCOCP) | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard S. Legro, M.D. | The Milton S. Hershey Medical Center | 717-531-6210 | rsl1@psu.edu |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Traditional OCP | Drug | (traditional OCP) (21 active days/7 inactive days) treatment regimen |
|
|
treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control Group (Traditional OCP) | treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |