Status:
COMPLETED
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-38 years
Phase:
PHASE3
Brief Summary
The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental ef...
Detailed Description
-Introduction The Polycystic Ovarian Syndrome (PCOS) is a frequent endocrine among women in reproductive ages, with a prevalence of 10%. In 2003, a consensus among the European and American Society of...
Eligibility Criteria
Inclusion
- All patients with polycystic ovarian syndrome will be invited to participate in the study. The PCOS criteria are according to modified Rotterdam criteria (7); i.e., oligoovulation defined as \< 6 menstrual periods per year, signs of clinical hyperandrogenism (Ferriman and Gallwey \>8) or laboratorial (total Testosterone \>=0.81 ng/dL) or polycystic ovary \> 10cm3.
- Furthermore, all patients with infertility diagnosis based solely on ovulation factor will included in the protocol
- Age \>18 years old and \<= 38 years old.
- No endometriosis on laparoscopy
Exclusion
- Not willing to participate in the study
- use of IUD or contraceptive pill within 2 months before the study.
- Hyperprolactinemia (\>20ng/mL)
- Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL).
- High 17-OH progesterone (\>=4.9ng/mL)
- Endometriosis
- Known allergy to clomiphene or raloxifene
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00427700
Start Date
August 1 2008
End Date
August 1 2009
Last Update
August 21 2024
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003