A Study of AZD4901 in Females With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01872078 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD4901 (oral) (Drug); Placebo to match AZD4901 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 |
1.118; 0.9729; 0.8804; 0.5364 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within the 6 months prior to screening.
Exclusion Criteria
Perimenopausal or reached natural menopause, defined as FSH > 10 IU/L. Menstruated within the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both. Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding.
Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.
Data sourced from ClinicalTrials.gov (NCT01872078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.