Background

• Many competitive women athletes experience menstrual irregularities.
• Menstrual irregularities include amenorrhea (the absence of a menstrual period) and oligomenorrhea (infrequent              menstruation). Athletes may also experience hidden abnormalities such as shortened luteal phase, and anovulatory cycles.
• Menstrual irregularities reflect low serum estrogen levels.
• Estrogen is a key hormone in bone deposition and maintenance.
• Women athletes with menstrual irregularities are at increased risk for low bone mass and stress fractures.

Intervention:

• Oral contraceptives contain estrogen and regulate the menstrual cycle.
• Estrogen replacement has been shown to prevent bone loss in post-menopasual women and in pre-menopausal women with medical conditions such as premature ovarian failure and hyperprolactinemia.
• It is unknown if estrogen replacement prevents bone loss in women athletes with menstrual irregularities, as the hypothesis has never been tested.

• This study is a randomized trial of oral contraceptive use in 150 female cross country runners.
• The study will test the hypothesis that oral contraceptives reduce stress fracture incidence and prevent loss of bone  mass or increase bone mass among highly trained female athletes.
• This study is important because it is the first trial to test the efficacy of oral contraceptives as a bone health intervention among women athletes.
• Interested runners will be screened for eligibility via phone interview or email.
• Eligible athletes agreeing to participate will visit one of the five clinical sites in the U.S. to be screened for oral contraceptive use and to complete a baseline bone scan. They will complete also complete a food questionnaire and a training questionnaire.
• Athletes will be randomly assigned to either the treatment group, which takes a oral contraceptive (Lo/Ovral) containing 30 micrograms of estrogen, or to the control group, which takes nothing. PLEASE NOTE: Participants cannot select their own group. B-FIT will supply the oral contraceptive for the duration of the study
• One year after the baseline bone scan, athletes will complete the food and training questionnaires again and return to the clinical site for a second bone scan.
• Two years after the baseline bone scan athletes will have their final bone scan and fill out the training and food questionnaires again. At this time, the committment to B-FIT is fulfilled.
• Throughout the two years of participation, athletes will keep a menstrual calendar and will contact the B-FIT office if a stress fracture is suspected or diagnosed.

Participants must be:

• Female and between the ages of 18 - 25
• Running competitively, approximately 30+ miles a week, competing in races a plus
• Not currently taking oral contraceptives or estrogen replacement
• Willing to be randomized into either treatment (oral contraceptive group) or control (no OC group)
• Close to Stanford, U.C.L.A or N.Y.C. (travel expenses reimbursed)
• OR a student at Bowdoin, Cal Poly SLO, Cal Poly Pomona, CalState Fresno, CalState Stanislaus, Connecticut College, Dartmouth College, Lehigh University, Michigan State University, University of Michigan, Oakland University, Monmouth College, Mount Holyoke College, Santa Clara University, San Diego State University, Springfield College, University of New Hampshire, University of Vermont, or Vassar College.

Benefits:

• A test for bone density (DXA), usually $200-$500, free to all participants
• Diet analysis
• Body composition measurements
• Running gifts including a subscription to Running Times magazine
• Reimbursed travel to and from the bone testing site
• The chance to participate in an important women's health study and help the advancement of women's sports and female athletes everywhere!

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