Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism

PHASE4CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

June 30, 2012

Study Completion Date

December 31, 2012

Conditions
Turner SyndromeHypogonadismPremature Ovarian Failure
Interventions
DRUG

17 B estradiol orally

Group A will be given estrogen by mouth daily(0.5 mg or 1mg or 2 mg of 17B Estradiol. Doses will vary depending on the blood levels of estrogen starting with the lower doses and adjusting these doses up as needed to keep the levels in the normal range. The estrogen will be taken for 21 days. In order to have a menstrual cycle progesterone will be given for 7 days, starting from day 14 through day 21 of each cycle. Then both medications are stopped on day 21 for a total of 7 days. Labs will be obtained at baseline, 1,2,3,6,9 and 12 months. Dual-energy X-ray absorptiometry (DXA) scan and calorimetry will be done at baseline and at 6 and 12 month.

DRUG

17 B estradiol

Group B will be given estrogen via a patch applied to the skin twice a week (0.375mg or 0.05mg or 0.075mg) Doses will vary depending on the blood levels of estrogen starting with the lower doses and adjusting these doses up as needed to keep the levels in the normal range. The estrogen will be taken for 21 days. In order to have a menstrual cycle progesterone will be given for 7 days, starting from day 14 through day 21 of each cycle. Then both medications are stopped on day 21 for a total of 7 days. Labs will be obtained at baseline, 1,2,3,6,9 and 12 months. Dual-energy X-ray absorptiometry (DXA) scan and calorimetry will be done at baseline and at 6 and 12 month.

Trial Locations (3)

19107

Jefferson Medical College of Thomas Jefferson University, Philadelphia

32207

Nemours Children's Clinic, Jacksonville

Unknown

University of Chile/Clinica las Condes, Santiago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Nemours Children's Clinic

OTHER

NCT00837616 - Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism | Biotech Hunter | Biotech Hunter