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Polycystic Ovary SyndromePhase 2OWL-PCOSNCT00704912

Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women

A Phase 2 study testing Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20 and Combination of treatments in people with Polycystic Ovary Syndrome, run by Milton S. Hershey Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20 and Combination of treatments
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
2 sitesUnited States
Study dates
Sep 2008to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chronic anovulation or oligomenorrhea defined as intermenstrual periods of >= 45 days or a total of <=8 periods per year.
  • Hyperandrogenism will be an elevated total testosterone >=50 ng/dL.
  • Hirsutism determined by a modified Ferriman-Gallwey Score >8.
  • PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter).
  • BMI >=27 to <=42.
  • Normal EKG to rule out any abnormalities with the heart.

Who cannot join

  • Current pregnancy.
  • Patients on oral contraceptives, depo progestins, or hormonal implants.
  • Patients with hyperprolactinemia defined as two prolactin levels at least one week apart >30 ng/mL.
  • Patients with known 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone (17-OHP) level <2 ng/mL and ACTH stimulation test as needed, or other enzyme deficiency.
  • Patients with menopausal FSH levels >20 mIU/mL.
  • Patients with uncorrected thyroid disease (TSH <0.45 mIU/ML or >4.5 mIU/ML).
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  • Patients diagnosed with Type1 or Type II diabetes.
  • Patients with liver disease defined as AST or ALT >2 times normal or total bilirubin >2.5 mg/dL.
  • Patients with renal disease defined as BUN >30 mg/dL or serum creatinine >1.4 mg/dL.
  • Patients with significant anemia (Hemoglobin <10 mg/dL).
  • Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
  • Patients with known heart disease that is likely to be exacerbated by pregnancy.
  • Patients with a history of , or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal PAP smear or reassuring colposcopy based on current ACOG guidelines will be required.
  • Patient with current history of alcohol abuse.
  • Patients enrolled simultaneously into other investigative studies.
  • Patients taking other medications know to affect reproductive function or metabolism.
  • Patients with a suspected adrenal or ovarian tumor secreting androgens.
  • Patients with suspected Cushing's syndrome.
  • Patients who have undergone a bariatric surgery procedure in the recent past (<12 months).
  • Patients with untreated poorly controlled hypertension defined as systolic blood pressure >=150 mm Hg or average diastolic >=100 mm Hg on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure >= 140 mm Hg or average diastolic >= 90 mm Hg.
  • Patients with medical conditions that represent contraindications to orlistat, OCP, clomiphene, and/or pregnancy.
  • Patients currently participating in lifestyle intervention program (Weight Watchers, Atkins Diet, Curves) or lost more than 5% body weight within the last 6 months.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Pennsylvania, Department of Obstetrics and Gynecology

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women

The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.

Read the detailed description

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among women, and women with PCOS are at increased risk for pregnancy complications such as gestational diabetes and pre-eclampsia. Both hyperandrogenism (HA) and obesity exacerbated insulin resistance (IR) are characteristics of the syndrome, and are targets for treatment, but which should be the predominant focus is still unknown. Phase 1 of this study will be a randomized trial of three preconception interventions in infertile women with PCOS. The first arm will be a combined intervention of medication, meal replacements, and lifestyle modification to improve IR. Orlistat is a gastric lipase inhibitor that reduces the absorption of fat contained in a meal by about 30%. The second arm will be the use of a continuous OCP for 4 months to improve HA. Lo-Estrin 1/20 will be used in a continuous method for 4 months to suppress the ovary. The third arm is the combination of both to improve HA an IR. Phase II of this study will involve ovulation induction with clomiphene citrate with hopeful outcome of pregnancy. Finally, Phase III involve following the pregnancies for outcomes and complications.

Being tested
Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20, Combination of treatments
Keywords
Polycystic Ovary Syndrome
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orlistat/Meal Replacement/Lifestyle ModificationDrug

    Also called Orlistat, Alli, Lifestyle Intervention, Weight Loss

    Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.

  • Loestrin 1/20Drug

    Also called OCP, Oral Contraceptive

    Patients will be started on a low dose containing OCP for a continuous 4 month period.

  • Combination of treatmentsDrug

    Also called Orlistat, Alli, OCP, Oral Contraceptive

    Medications will be administered as described for the other 2 arms.

Study groups in NCT00704912
Study groupRoleWhat they receive
Lifestyle interventionActive comparatorOrlistat/Meal Replacement/Lifestyle Modification
Receives: Drug: Orlistat/Meal Replacement/Lifestyle Modification
Oral Contraceptives (OCP)Active comparatorLoestrin 1/20
Receives: Drug: Loestrin 1/20
Lifestyle/OCP CombinedActive comparatorCombination of treatments
Receives: Drug: Combination of treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live Birth Rate

    Measured: Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.

Secondary outcomes (3)

  1. Ovulation Rate

    Measured: Up to 4 months

  2. Change in Weight

    Change from baseline to end of the 4-month intervention.

    Measured: Baseline, 4 months

  3. Prevalence of Metabolic Syndrome

    Measured: Baseline, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704912
Sponsor's protocol ID
27184
Acronym
OWL-PCOS
Status last verified
Nov 2016
First submitted
23 Jun 2008
Last updated
7 Nov 2016
Data monitoring committee
Yes

Publications

  • Steinberg Weiss M, Roe AH, Allison KC, Dodson WC, Kris-Etherton PM, Kunselman AR, Stetter CM, Williams NI, Gnatuk CL, Estes SJ, Sarwer DB, Coutifaris C, Legro RS, Dokras A. Lifestyle modifications alone or combined with hormonal contraceptives improve sexual dysfunction in women with polycystic ovary syndrome. Fertil Steril. 2021 Feb;115(2):474-482. doi: 10.1016/j.fertnstert.2020.08.1396. Epub 2020 Oct 12.

    PubMed 33059886

  • Shah A, Dodson WC, Kris-Etherton PM, Kunselman AR, Stetter CM, Gnatuk CL, Estes SJ, Allison KC, Sarwer DB, Sluss PM, Coutifaris C, Dokras A, Legro RS. Effects of Oral Contraception and Lifestyle Modification on Incretins and TGF-ss Superfamily Hormones in PCOS. J Clin Endocrinol Metab. 2021 Jan 1;106(1):108-119. doi: 10.1210/clinem/dgaa682.

    PubMed 32968804

  • Dokras A, Sarwer DB, Allison KC, Milman L, Kris-Etherton PM, Kunselman AR, Stetter CM, Williams NI, Gnatuk CL, Estes SJ, Fleming J, Coutifaris C, Legro RS. Weight Loss and Lowering Androgens Predict Improvements in Health-Related Quality of Life in Women With PCOS. J Clin Endocrinol Metab. 2016 Aug;101(8):2966-74. doi: 10.1210/jc.2016-1896. Epub 2016 Jun 2.

    PubMed 27253669

  • Legro RS, Dodson WC, Kunselman AR, Stetter CM, Kris-Etherton PM, Williams NI, Gnatuk CL, Estes SJ, Allison KC, Sarwer DB, Diamond MP, Schlaff WD, Casson PR, Christman GM, Barnhart KT, Bates GW, Usadi R, Lucidi S, Baker V, Zhang H, Eisenberg E, Coutifaris C, Dokras A. Benefit of Delayed Fertility Therapy With Preconception Weight Loss Over Immediate Therapy in Obese Women With PCOS. J Clin Endocrinol Metab. 2016 Jul;101(7):2658-66. doi: 10.1210/jc.2016-1659. Epub 2016 May 12.

    PubMed 27172435

  • Legro RS, Dodson WC, Kris-Etherton PM, Kunselman AR, Stetter CM, Williams NI, Gnatuk CL, Estes SJ, Fleming J, Allison KC, Sarwer DB, Coutifaris C, Dokras A. Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2015 Nov;100(11):4048-58. doi: 10.1210/jc.2015-2778. Epub 2015 Sep 24.

    PubMed 26401593

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20 and Combination of treatments in people with Polycystic Ovary Syndrome, run by Milton S. Hershey Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live Birth Rate (time frame: Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00704912, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.

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