Clinical trial · Interventional
Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome
Influence of Hyperandrogenemia on the Sleep-associated Slowing of Follicular LH Frequency in Adult Polycystic Ovary Syndrome
NCT00930228CI-TRIAL-00070997CRM004unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether a testosterone receptor blocker (flutamide) will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with polycystic ovary syndrome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flutamide | Drug | Flutamide | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flutamide
- description
- Flutamide 250 mg taken by mouth twice a day for 4 weeks. Flutamide is an androgen-receptor blocker.
- interventionNames
- Drug: Flutamide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Luteinizing hormone pulse frequency
- timeFrame
- One and two months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria for all participants: * Subjects will be 18-35 years old; we use a cutoff age of 35 y because early menopause at this age is very rare. * No significant health problems (other than PCOS and obesity). * Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods) during the time of study and must be willing and able to provide informed consent. Inclusion criteria for normal controls: * Controls will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism. Inclusion criteria for PCOS: * PCOS will be defined according to NIH consensus criteria. * As such, subjects with PCOS will have hyperandrogenism, whether it is clinical (e.g., hirsutism) or biochemical (i.e., elevated plasma T). * Subjects with PCOS will also have oligo- or amenorrhea (i.e., \< 7 periods per year) and no evidence for other endocrinopathies (e.g., hyperprolactinemia, Cushing's syndrome, etc.). Exclusion Criteria: * Being a study of GnRH pulse regulation in women with and without PCOS, men are excluded. * Obesity associated with a diagnosed (genetic) syndrome, obesity related to medications (e.g., glucocorticoids), etc. * Pregnancy or lactation. * Virilization. * A total testosterone \> 150 ng/dl in women with PCOS (which suggests the possibility of a virilizing neoplasm) (confirmed on repeat). * Elevated DHEAS (mild elevations may be seen in PCOS, and elevations \< 1.5 times the upper limit of normal will be accepted in PCOS)(confirmed on repeat). * Follicular 17-hydroxyprogesterone \> 300 ng/dl, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase and there is a concern about the possibility of congenital adrenal hyperplasia, the 17-hydroxyprogesterone may be collected during the follicular phase, or \>60 if oligomenorrheic). \*NOTE: If a 17-hydroxyprogesterone \> 300 ng/dl is confirmed on such repeat testing, an ACTH stimulated 17-hydroxyprogesterone \< 1000 ng/dl will be required for study participation. * A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c \> 6.5% * Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study will at the least be delayed pending appropriate treatment) (confirmed on repeat). * Abnormal prolactin (mild elevations may be seen in PCOS, and elevations \< 1.5 times the upper limit of normal will be accepted in this group) (confirmed on repeat). * Evidence of Cushing's syndrome by history or physical exam. * Hematocrit \< 36% or hemoglobin \< 12 g/dl (that is not reversed by iron treatment). * Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.) * Liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. * Abnormal sodium or potassium (confirmed on repeat); bicarbonate concentration \<20 or \>30 (confirmed on repeat); or elevated creatinine concentration (confirmed on repeat). * Due to the amount of blood being drawn in the study, subjects with body weight \< 110 lbs will be excluded from the study.
References
Publications (0)
Data not yet available
No reference posted for this study.