drugset / Trial / NCT00134745
Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome
Phase 4
Completed
43 enrolled
Line Cleemann
Novo Nordisk A/S · collabThe County of Frederiksborg · collabThe foundation of Kaptajnløjtnant Harald Jensen and Wife · collabThe foundation of Mr. Ivan Nielsen · collabThe foundation of Mrs. Olga Bryde · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The purpose of this study is to examine whether a larger dosage of estrogen than the one used today will secure the development of a normal sized uterus and increase the strength of the bones in girls and young women with Turner syndrome. The purpose is also to evaluate whether aortic dilatation is present in this group of patients, and if the estrogen dosage will influence the emotional well-being and self-esteem of the patients.
Timeline
- Start
- 2005-06
- Primary completion
- 2013-03
- Completion
- 2013-03
Publications
- Cleemann L, Holm K, Fallentin E, Moller N, Kristensen B, Skouby SO, Leth-Esbensen P, Jeppesen EM, Jensen AK, Gravholt CH. Effect of Dosage of 17ss-Estradiol on Uterine Growth in Turner Syndrome-A Randomized Controlled Clinical Pilot Trial. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz061. doi: 10.1210/clinem/dgz061.
- Brun S, Cleemann L, Holm K, Salskov G, Erlandsen M, Berglund A, Andersen NH, Gravholt CH. Five-Year Randomized Study Demonstrates Blood Pressure Increases in Young Women With Turner Syndrome Regardless of Estradiol Dose. Hypertension. 2019 Jan;73(1):242-248. doi: 10.1161/HYPERTENSIONAHA.118.11742.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estradiol | Other / unclassified | 2 mg | Oral |
| Comparator | Estradiol | Other / unclassified | 4 mg | Oral |