Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

Penn State Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dysmenorrhea

Treatments: Drug: CCOCP; Drug: Traditional OCP

Study type: Interventional

Funder types: Other

Identifiers

NCT00517556

25239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 2 patient groups

study group (CCOCP)

Experimental group

Description:

treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles

Treatment:

Drug: CCOCP

control group (traditional OCP)

Active Comparator group

Description:

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.

Treatment:

Drug: Traditional OCP