Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

NCT ID: NCT00517556

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-04-30

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.

Conditions

Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

study group (CCOCP)

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

Group Type: EXPERIMENTAL

CCOCP

Intervention Type: DRUG

(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol

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.

Group Type: ACTIVE_COMPARATOR

Traditional OCP

Intervention Type: DRUG

(traditional OCP) (21 active days/7 inactive days) treatment regimen

Interventions

CCOCP

(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol

Intervention Type: DRUG

Traditional OCP

(traditional OCP) (21 active days/7 inactive days) treatment regimen

Intervention Type: DRUG

Other Intervention Names

Oral contraceptives; Oral contraceptives

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard S Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Nova Gradiska General Hospital

Strossmayerova 17, , Croatia

Countries

Croatia

References

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.

Reference Type: DERIVED

PMID: 37523477 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22617578 (View on PubMed)

Other Identifiers

25239

Identifier Type: -

Identifier Source: org_study_id