An interventional study of Flutamide and Progesterone in Polycystic Ovary Syndrome and Hyperandrogenism, sponsored by University of Virginia. Terminated at 1 site in United States. Open to female participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-06-04.
Sponsored by University of Virginia · Not applicable, Interventional, and Basic science
The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators understand the effects of elevated male hormones levels in girls, the investigators may be able to better treat girls with elevated male hormone levels and perhaps even learn how to prevent the development of PCOS. Females with elevated levels of male hormones respond differently to estrace (estradiol) and progesterone than females with normal male hormone levels. The investigators will be giving you estrogen and progesterone to see how you respond after the male hormone has been blocked by a medication called flutamide.
Similar to women with PCOS, girls with hyperandrogenemia have an increased frequency of LH pulses when compared to age matched controls. An ongoing study by our group is investigating whether the progesterone insensitivity of the GnRH pulse generator in adult women with PCOS is also seen in adolescent girls with hyperandrogenemia. Analysis of the data to date suggests that the hyperandrogenic adolescent girls have decreased hypothalamic progesterone sensitivity when compared to adolescent controls, with a subgroup (consisting of approximately half of the hyperandrogenic girls) having marked progesterone insensitivity similar to that seen in adult women with PCOS. These data have recently been published.
Given that androgens mediate hypothalamic progesterone insensitivity in adult women with PCOS, we hypothesize that androgens play a similar role in adolescent girls with hyperandrogenemia and that progesterone sensitivity can be restored with the use of the androgen receptor blocker flutamide.
Better understanding the effects of hyperandrogenemia in adolescence and its role in the development of PCOS will hopefully lead to improved prevention and treatment strategies for PCOS. This may prove increasingly important if the current epidemic in childhood obesity results in a growing number of girls with elevated androgen levels.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 4 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
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Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.
Drug: Flutamide · Drug: Progesterone · Drug: estrace
Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day.
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
0.5-1 mg once a day for seven days
Also known as: (estradiol)
Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level
The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.
Time frame: 3 weeks after flutamide treatment
| Milestone | Flutamide, Estrace, Progesterone |
|---|---|
| Started | 4 |
| Completed | 2 |
| Not completed | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Elevated screening liver enzymes | 1 |
The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.
| percentage of slope change | Flutamide, Estrace, Progesterone |
|---|---|
| Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level | -0.55 |
Collected over Two weeks post study drug intervention, at time of last blood draw.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flutamide, Estrace, Progesterone | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Event | Flutamide, Estrace, Progesterone |
|---|---|
| Mood change, sadnessSocial circumstances | 1/4 |
| Age, Categorical(Participants) | Flutamide, Estrace, Progesterone |
|---|---|
| <=18 years | 4 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Flutamide, Estrace, Progesterone |
|---|---|
| Mean | 15.5 (14 to 17) |
| Sex: Female, Male(Participants) | Flutamide, Estrace, Progesterone |
|---|---|
| Female | 4 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Flutamide, Estrace, Progesterone |
|---|---|
| White | 4 |
| Region of Enrollment(Participants) | Flutamide, Estrace, Progesterone |
|---|---|
| United States | 4 |
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