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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00946192 |
Purpose
The purpose of this study is to determine if transdermal estrogen or oral estrogen are effective in the treatment of amenorrhea in adolescent athletes. Special attention will be paid to how these treatments affect bone health in these patients. The investigators hypothesize that transdermal estrogen will be more effective than oral estrogen or no estrogen in improving bone health in amenorrheic adolescent athletes.
| Condition | Intervention | Phase |
|---|---|---|
|
Amenorrhea Female Athlete Triad Syndrome |
Drug: Transdermal 17Beta-estradiol, progesterone Drug: Ethinyl Estradiol + Desogestrel Dietary Supplement: Elemental Calcium and Vitamin D |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes |
| Estimated Enrollment: | 230 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Estrogen Patch: Experimental
17Beta-estradiol transdermal patch twice weekly application for 12 months
|
Drug: Transdermal 17Beta-estradiol, progesterone
100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily
|
|
Estrogen Pill: Active Comparator
One pill containing estrogen and progesterone taken daily for 21 days followed by one pill containing progesterone only for 7 days; regimen repeated for 12 months.
|
Drug: Ethinyl Estradiol + Desogestrel
Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily
|
| No Estrogen: No Intervention |
Dietary Supplement: Elemental Calcium and Vitamin D
Elemental calcium 1200 mg and Vitamin D 400 IU taken once daily
|
As many as 25% of adolescent and young adult endurance athletes develop amenorrhea, and factors that cause amenorrhea to occur in some, but not all, athletes have not been well characterized. Recent data indicate the critical importance of a negative energy balance state and leptin in regulating the Hypothalamic-pituitary-gonadal (H-P-G) axis. However, these factors do not completely account for alterations in this axis, and other contributing factors are unclear. Our preliminary data indicate the importance of low fat mass and fat related hormones in mediating hypogonadism in young athletes. This study will confirm these data and determine whether low fat mass and altered levels of adipokines, such as leptin and adiponectin, and hormones regulated by fat mass, such as ghrelin and peptide YY (PYY), determine alterations in LH pulsatility. A very concerning impact of amenorrhea in athletes is low bone mineral density (BMD). Preliminary data indicate lower BMD in adolescent athletes with amenorrhea (AA) compared with eumenorrheic athletes (EA) and non-athletic controls. The high prevalence of AA in adolescents is particularly concerning, because this population is potentially at greater risk as it is actively accruing bone. Of importance, bone microarchitecture, a better predictor of bone strength than BMD, has not been studied in AA. Because pubertal increases in estrogen are integral to optimizing peak bone mass, and AA is characterized by hypoestrogenism, this randomized study of transdermal estrogen versus oral estrogen or no estrogen will also examine whether estrogen replacement increases BMD and improves bone microarchitecture in adolescent AA 14-21 years old. EA and sedentary controls will be followed without intervention for this period. Despite the prevalent practice of prescribing oral contraceptives in AA, there is a paucity of data regarding benefits of this intervention in teenagers. Because transdermal estrogen, unlike oral estrogen, does not suppress IGF-1, an important bone anabolic factor, we expect effects of transdermal estrogen to exceed those of oral estrogen or no therapy. In addition, preliminary data indicate that low fat mass and alterations in fat related hormones may contribute to decreased bone accrual rates in athletes, and will be confirmed in this study. To summarize, a better understanding of the pathophysiology of reproductive dysfunction is critical to develop therapeutic strategies that will normalize the reproductive axis and bone accrual, and these are the questions that this study aims to answer.
Eligibility| Ages Eligible for Study: | 14 Years to 21 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Madhusmita Misra, MD, MPH | 617-724-5602 | mmisra@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Madhu Misra, M.D. 617-724-5602 mmisra@partners.org | |
| Contact: Nara Mendes, B.A. 617 724 6046 nmendes1@partners.org | |
| Principal Investigator: Madhu Misra, M.D. | |
| Principal Investigator: | Madhusmita Misra, MD, MPH | Massachusetts General Hospital Pediatric Neuroendocrine Unit and Harvard Medical School |
More Information
| Responsible Party: | MassGeneral Hospital for Children and Harvard Medical School ( Madhusmita Misra, MD, MPH/ Program Director, Pediatric Endocrinology ) |
| Study ID Numbers: | 2009P000353, R01 HD060827-01A1 |
| Study First Received: | July 22, 2009 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00946192 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Amenorrhea Adolescent Endurance Athletes |
Females Osteopenia Osteoporosis Estrogen |
|
Progesterone Contraceptive Agents Gonadal Disorders Contraceptives, Oral Physiological Effects of Drugs Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Amenorrhea Bone Density Conservation Agents Reproductive Control Agents Estradiol 17 beta-cypionate Hormones Bone Diseases Prune Belly Syndrome |
Pathologic Processes Desogestrel Musculoskeletal Diseases Menstruation Disturbances Mental Disorders Progestins Therapeutic Uses Estradiol 3-benzoate Syndrome Vitamins Abnormalities, Multiple Female Athlete Triad Syndrome Contraceptives, Oral, Synthetic Micronutrients Congenital Abnormalities |