Letrozole Treatment in Normal and GnRH Deficient Women
Paraules clau
Resum
Descripció
The negative feedback control of FSH is crucial for the precise regulation of follicular development in the female. An important component of this feedback is exerted by estrogen. Letrozole will be used to block aromatase and therefore estradiol production in normal and GnRH deficient females. These studies will dissect the relative roles of estradiol and inhibin on FSH secretion at the pituitary and hypothalamus.
The aromatase inhibitors block aromatization of androgens to estrogens, allowing us to examine the relative contribution of estradiol and the inhibins to FSH regulation. The use of a submaximal dose of a GnRH antagonist will allow us to estimate the overall amount of GnRH secreted (hypothalamic contribution) with and without aromatase inhibition.
A more thorough understanding of estrogen and inhibin feedback on FSH will improve our understanding of the failure of follicle development in subsets of patients with infertility, such as polycystic ovary syndrome, in which FSH levels are normal but follicles fail to develop. Study of FSH control will also help us understand the failure of negative feedback on FSH, which can result in multiple follicular development and multiple gestation and its associated costs and risks. Thus, these studies may afford new therapeutic options for conception in infertile patients while simultaneously providing new methods to avoid the risks of multiple gestations.
Dates
| Darrera verificació: | 05/31/2017 |
| Primer enviat: | 07/09/2006 |
| Inscripció estimada enviada: | 07/09/2006 |
| Publicat per primera vegada: | 07/11/2006 |
| Última actualització enviada: | 06/27/2017 |
| Publicació de l'última actualització: | 07/26/2017 |
| Data dels primers resultats enviats: | 03/15/2017 |
| Data dels primers resultats de control de qualitat enviats: | 03/15/2017 |
| Data dels primers resultats publicats: | 04/26/2017 |
| Data d'inici de l'estudi real: | 01/20/2004 |
| Data estimada de finalització primària: | 06/28/2009 |
Condició o malaltia
Intervenció / tractament
Drug: Letrozole
Drug: NAL-GLU GnRH antagonist
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Aromatase inhibitor EFP Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted. | |
| Experimental: Aromatase inhibitor LFP Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | Female |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: Healthy Normal Subjects will meet the following criteria: - 18 to 35 years of age - good general health - on no medications including any hormonal drug products for at least 3 months before the study - regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone > 3 ng/ml - no evidence of androgen excess - normal TSH, prolactin and hemoglobin - use of double-barrier contraception, permanent sterilization or abstinence during the cycle of study. - Negative pregnancy test (serum) at the beginning of each cycle of study - Normal Liver Function Test Exclusion Criteria: - History of liver and/or kidney disease - Substance or alcohol abuse - Hormone dependent neoplasia including breast cancer - Women who are trying to become pregnant |
Resultat
Mesures de resultats primaris
1. FSH Level [EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mm]
