Clinical Connection Home
  Welcome To
Clinical Connection
 

Trials
Alerts

Trials
Search

Health
Forum

Health
News

RSS

Intro

Clinics &
Sponsors

Member
Login
View Clinical Trial (Medical Research Study)

Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women - NCT00704912-19104 (Clinical Trial 228906)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy228906.aspx



** Please review additional "Nearby Studies" on right ----->

This is an archived study that is no longer available, if you
would like to find active studies please search our studies.
Clinical Trials Notification
Clinical Trials Search

City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Polycystic Ovary Syndrome
Purpose: 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.
Study summary: 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. Sibutramine is a combined norepinephrine-serotonin re-uptake inhibitor that is associated with increased satiation (fullness) and a resulting reduction in food intake. 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.
Criteria: Inclusion Criteria: - Partner with sperm concentration of >=14 million/mL in at least one ejaculate with motile sperm. - Ability to have regular intercourse 2-3 times per week during the ovulation induction phase of study. - At least on patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years. - No previous sterilization procedures(vasectomy, tubal ligation) tha have been reversed. Exclusion Criteria: - Intermenstrual periods of >= 45 days or a total of <=8 periods per year. - Elevated total testosterone >50 ng/dL. - PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter). - BMI >=27 to <=40.
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.

Data Source: ClinicalTrials.gov
Date Processed: February 16, 2010
Modifications to
this listing:
Only selected fields are shown, please use the link above to view all information about this clinical trial.

 
 
 
 
 
 
 
 












Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


Within 25 Miles

Pregancy in Polycystic Ovary Syndrome II - Philadelphia PA

Metastatic Colorectal Cancer - PEAK Study - Philadelphia PA

Depression - Cherry Hill NJ

Depression - Cherry Hill NJ

Bipolar Depression - Media PA

Depression - Media PA

Alzheimer's Disease - Norristown PA

Depression - Norristown PA

Alzheimers Disease - Norristown PA

Elderly Insomnia - Collegeville PA

Diabetic Gastroparesis - Limerick PA



Within 50 Miles

Healthy Volunteers (Females Ages 18-40) - Plainsboro NJ

Elderly Insomnia - Allentown PA

Stress Urinary Incontinence - Allentown PA



Within 100 Miles

Osteoarthritis - Lancaster PA

Irritable Bowel Syndrome with Constipation (IBS-C) - Lancaster PA

Diabetes - Neptune NJ

Metastatic Colorectal Cancer - PEAK Study - Morristown NJ

Metastatic Colorectal Cancer - PEAK Study - Denville NJ

Metastatic Colorectal Cancer - PEAK Study - Sparta NJ

Diabetes with Breathing Condition (COPD, Asthma, Chronic Bronchitis, or Emphysema) - New York NY

Diabetes - New York NY

COPD (Chronic Obstructive Pulmonary Disease) - New York NY

Pain Medication - New York NY

Adult Attention-Deficit Disorder (ADD) with Nicotine Use - New York NY

Major Depressive Disorder - New York NY

Treatment-Resistant Depression - New York NY

Metastatic Colorectal Cancer - PEAK Study - Baltimore MD

Elderly Insomnia - New York NY

Restless Legs Syndrome (RLS) - New York NY

Menstrual Migraine - New York NY

Osteoarthritis of the Knee - Manhattan NY

ADHD and Hyperactivity (Ages 6-17) - New York NY

Elderly Insomnia - New York NY

Sleep Apnea - Baltimore MD

Obstructive Sleep Apnea - Baltimore MD

Diabetic Gastroparesis - New York NY

Social Anxiety Disorder - New York NY

Major Depressive Disorder - New York NY

Healthy Volunteers (Females Ages 18-40) - Baltimore MD

Healthy Volunteer (Ages 18-65) - Baltimore MD

Healthy Volunteers - Baltimore MD

Healthy Caucasian Males - Baltimore MD

Healthy Post Menopausal Women - Baltimore MD

Elderly Insomnia - Pikesville MD

Psoriasis - Paramus NJ

Painful Sore Throat - Paramus NJ

Healthy Volunteers - Baltimore MD

Healthy Female Volunteers (Ages 18-55) - Baltimore MD

Psoriasis (Ages 18-65) - Baltimore MD

Overweight Volunteers (Males 18-45) - Baltimore MD

Healthy Volunteer (Ages 18+) - Baltimore MD

Healthy Volunteers (Ages 18-55) - Baltimore MD

Healthy Overweight Volunteers - Baltimore MD

Treatment Response in Depression - Englewood Cliffs NJ

 
Home | Clinical Trials Notification | Search Clinical Trials | About Clinical Trials | Message Board | Investigators
Links | Terms And Conditions | Sitemap | Suggestion/Feedback
© 1998-2009 | All trademarks are property of their legal owners. | All Rights Reserved

ClinicalConnection.com is a resource that provides individuals with information regarding clinical trials that are being conducted nationwide.
ClinicalConnection.com does not conduct these clinical trials nor endorse them. Please consult your doctor or physician before participating.