Please assess the completion status of the following clinical trial:

Trial Title: Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 10.0

Eligibility Criteria:
Inclusion Criteria:~* PCOS subjects will be recruited from the Endocrinology Clinics of the University of Chicago. All will be at least 2 years post-menarche and less than 40 years of age. A diagnosis of PCOS will require:~  * the presence of oligo/amenorrhea;~ * hyperandrogenemia, defined by a supranormal plasma free testosterone level (\> 10 pg/ml);~ * hyperandrogenism, as evidenced by infertility, hirsutism, acne, or androgenetic alopecia; and~ * exclusion of nonclassic 21-hydroxylase deficiency congenital adrenal hyperplasia, Cushing's syndrome, hypothyroidism, or significant elevations in serum prolactin. Thus, all subjects will meet the National Institutes of Health (NIH) consensus criteria for PCOS.~* Control subjects will be matched, as closely as possible, for age, ethnicity, body mass index (BMI), and body fat distribution \[as assessed by single cut abdominal computed tomography (CT) scan and dual energy x-ray absorptiometry (DEXA) scan\].~* Normal lean (BMI \<25 kg/m2) women will be between 18 and 40 years of age, in good health, with normal menstrual cycles, no sleep complaints, no history of endocrine disorder. All studies will be initiated in the early follicular phase (days 2-4).~Exclusion Criteria:~* For at least 2 months before the study, all subjects (PCOS and control) must not take steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Aim 1: Placebo (Type: NO_INTERVENTION): One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
- Aim 1: Pioglitazone (Type: EXPERIMENTAL): One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
- Aim 1: Leuprolide + Estrogen/Progestin (Type: EXPERIMENTAL): One of the 3 treatment arms in Aim 1: depot leuprolide plus estrogen/progestin replacement. No subjects were randomized to this arm.
- Aim 2: PCOS + SDB (Type: EXPERIMENTAL): One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
- Aim 2: Matched Controls (Type: EXPERIMENTAL): One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP). The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
- Aim 3: REM frag - SWS supp - Baseline (Type: EXPERIMENTAL): Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.
- Aim 3: REM frag - Baseline - SWS supp (Type: EXPERIMENTAL): Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
- Aim 3: Baseline - REM frag - SWS supp (Type: EXPERIMENTAL): Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
- Aim 3: SWS supp - REM frag - Baseline (Type: EXPERIMENTAL): Each subject was assessed under three experimental conditions in the following order.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.
- Aim 3: Baseline - SWS supp - REM frag (Type: EXPERIMENTAL): Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy