Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, continuous OCP
Brief summary
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.
Detailed description
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.
Interventions
DRUGCCOCP
(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
DRUGTraditional OCP
(traditional OCP) (21 active days/7 inactive days) treatment regimen
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women ages 18-35 with a history of PD (onset \< 3 years after menarche). * Subjects must have had regular (25-31 day) menstrual cycles for the three month period preceding enrollment, with symptoms of moderate to severe PD during those cycles.
Exclusion criteria
* Patients who have contraindications to OCP therapy. * Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome). * Concomitant treatment with oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs. * The use of contraceptive implants, injectable contraceptives or intrauterine devices. The washout period on all these medications will be 3 months. * Migraines, depression requiring hospitalization or associated with suicidal ideation during previous estrogen or ocp use. * Known or suspected hypersensitivity to trial drug. * Patients enrolled simultaneously into other investigative studies that require meds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Score | Baseline and 6 months | 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. |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group (CCOCP) treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles | 19 |
| 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. | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Study Group (CCOCP) | Control Group (Traditional OCP) | Total |
|---|---|---|---|
| Age, Continuous | 20.47 years STANDARD_DEVIATION 3.91 | 21.00 years STANDARD_DEVIATION 4.03 | 20.74 years STANDARD_DEVIATION 3.92 |
| BMI | 21.20 kg/m^2 STANDARD_DEVIATION 3.23 | 20.36 kg/m^2 STANDARD_DEVIATION 1.77 | 20.78 kg/m^2 STANDARD_DEVIATION 2.6 |
| Region of Enrollment Croatia | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Group (CCOCP) | Change in Visual Analog Scale (VAS) Score | -74.8 units on a scale |
| Control Group (Traditional OCP) | Change in Visual Analog Scale (VAS) Score | -58.7 units on a scale |
p-value: 0.05Mixed Models Analysis