Studies Open for Enrollment

A Randomized, Double-Blind Study to Evaluate the Efficacy of an Extended Cycle Combination Oral Contraceptive (DP3-84/10) for the Treatment of Menstrual-Related Pelvic Pain in Adolescents

The purpose of this study is to study the effectiveness of the oral contraceptive DP3-84/10 in reducing severe to moderate menstrual-related pelvic pain (menstrual cramps) in adolescents. The study medication is an experimental combined hormone pill that has been approved by the Food and Drug Administration (FDA) for birth control, but not for treatment of menstrual cramps. For this study, it will not be administered in a manner to prevent pregnancy. The sponsor is recruiting about 120 young women to participate, and about 25 young women are expected to take part in the study at Children’s Hospital of Pittsburgh of UPMC.

Candidates
Girls under the age of 18 who have menstrual cramps severe enough to interfere with daily activities and which require the use of over-the-counter pain medicine, and who meet other eligibility requirements are eligible to take part in this study.
Boys: N/A
Girls: Under 18 years

Requirements
Study participants will visit the research clinic 6 times during the 6-month study period. A physical examination will be conducted at the first visit to determine the participant’s eligibility to take the medication. The study medication or a placebo will be dispensed at subsequent visits, and follow-up tests will be conducted as well. Participants will receive a diary to complete with information related to their menstrual cramps.
Visits: 6
Duration: 6 months

Status: Open for Enrollment

How to Participate
To get started, please contact:
Lauren (Hughes) Hartz
412-692-6309

Additional Resources
Menstrual cycle

Principal Investigator
Gina S. Sucato, MD, MPH
Adolescent Medicine

Source of Support
Duramed Research, Inc.