A Phase 1 interventional study of Flutamide and Placebo in Polycystic Ovary Syndrome, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by University of Virginia · Phase 1, Interventional, and Other
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.
During the follicular phase of the normal menstrual cycle, luteinizing hormone (LH) pulse frequency decreases during sleep. These decreases may be important to support follicle stimulating hormone (FSH) synthesis and secretion. Polycystic ovary syndrome (PCOS) is associated with a persistently rapid gonadotropin hormone-releasing hormone (GnRH) pulse frequency, an abnormality that may account for many of the hormonal manifestations of PCOS. Although one prior study suggests that nocturnal LH frequency decreases slightly in PCOS, methodological issues limit interpretation. Our preliminary data suggest that nocturnal LH frequency does not decrease in untreated PCOS, but that nocturnal decreases of LH frequency are restored with androgen receptor blockade (flutamide) in women with PCOS. We have two hypotheses: (1) Prior to flutamide administration, sleep-associated slowing of LH pulse frequency is less pronounced in women with PCOS compared to that of normally-cycling women in the late follicular phase of the menstrual cycle; (2) After 4 weeks of flutamide administration, sleep-associated LH frequency reduction in women with PCOS is similar to that of normally-cycling women in the late follicular phase of the menstrual cycle. Women with PCOS and normally-cycling women will be studied. For each study participant, LH pulse frequency will be determined (from 1500 to 0700 h) after 4 weeks of flutamide and after 4 weeks of placebo. Flutamide and placebo will be given in random order (i.e., cross-over study). Sleep will be formally evaluated. Flutamide will then be given for 4 weeks prior to reassessment of LH pulse frequency. LH pulse frequency will be analyzed by way of hierarchical mixed effect models. We will use statistical analyses to determine: (a) whether the wake vs. sleep difference in LH frequency is the same for PCOS and normal controls prior to flutamide, and (b) whether the mean wake vs. sleep difference in LH frequency is the same for the two groups after flutamide.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's planned enrollment of 72 is close to the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Inclusion Criteria:
Inclusion criteria for all participants:
Inclusion criteria for normal controls:
Inclusion criteria for PCOS:
PCOS will be defined according to NIH consensus criteria.
Exclusion Criteria:
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.
Flutamide 250 mg taken by mouth twice a day for 4 weeks. Flutamide is an androgen-receptor blocker.
Drug: Flutamide
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
Drug: Placebo
Flutamide, 250 mg capsule for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)
Also known as: Eulexin
Placebo, for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)
Luteinizing hormone pulse frequency
Time frame: One and two months
Luteinizing hormone pulse amplitude
Time frame: One and two months
Mean luteinizing hormone level
Time frame: One and two months
Mean follicle stimulating hormone level
Time frame: One and two months
Sleep study parameters
Sleep study parameters (sleep stage, overnight ventilatory variables) will be assessed when available
Time frame: One and two months
Plan to share: Undecided — We do not have current plans to share IPD
No publications or documents are linked to this record.
The record gives a start of Jan 2009, a primary completion of May 2024 and a completion of Aug 2024. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Flutamide