Maximum dose of letrozole should be no more her2 than 37.5 mg / cycle. The treatment should be up to 5 cycles or about 25 weeks, continued. With 5 cycles of treatment, patients who are resistant to drugs to study at lower doses two to three cycles of treatment to the h Chsten dose of study medication will be. The number of ovulations is not a factor in determining treatment cycles, k Can no longer than 5 A double-blind study is needed to test our hypotheses and to establish the safety and efficacy of letrozole compared with the current gold standard, ie CC induction of ovulation in women with PCOS. To obtain the double-blind, CC and letrozole is overencapsulated packaged and numbered in sets contained identical study, which will then be sent directly to each clinical.
The NMR used this method successfully in the CC PPCOS GSK1904529A I study. 2.4. Randomization, seven hundred and fifty women will be randomized to one of two treatment groups and conditions. With a 1:1 ratio Ratio of treatment, it is about 375 women assigned to each treatment group to be. The scheme is a stratified permuted block randomization to be within each layer. The stratification variable will be at each site. Almac statistician, the system generates for the randomization of the study. Since this is a double-blind study, the randomization scheme to CDC data manager to be disclosed, but not all investigators NMR or employees, including the chief investigator of the protocol. The inspector on site, an account password for WebEZ, which is a secure web service protected by randomization are provided.
After the participants signed a Einverst Ndniserkl Tion and all the procedures necessary baseline assessment was completed, an investigator or a designated WebEZ will connect to a randomized participants in the study. The WebEZ rderf is the website for more information about F Ability of participants to query. If the member is entitled to the website will be provided with a user name and a number of study participants package. The study coordinator at each site is responsible for the warehousing, distribution and implementation of the pill I a reward to the study medication. 2.5. A specific study visits and procedures Spots U study periods are shown in Table 1. Visits after screening and Bank Transfer is a monthly cycle of two visits.
The first visit is a monthly visit midluteal the questions, a brief examination, ultrasound and blood tests, and the second visit, a visit at the time of menstruation, or if its the rules will be included are, not for a captured screen from pregnancy serum again from the dose of medication. This second test can be performed off-site to reduce the stress involved in the study. 2.5.1. Visit 1: screening visit, the goal of screening is to establish a diagnosis of polycystic ovary syndrome, with important medical diseases exclude s, and verify that it is not other important factors in infertility torque. Gr E, weight, blood pressure and waist and hip measurements are obtained. All participants that are 21 years or Older should have a normal Pap smear than the current American College of Obstetricians and Gyn Kologe recommended guidelines. An assessment is the GE score Be performed hirsutism Ferriman Gallwey hirsutism changed by trained personnel study. It is an assessment of acne crazy