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The Women's Health Study: From Adolescence to Adulthood

This study is currently recruiting participants.
Verified June 2017 by Marc R Laufer, Boston Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738204
First Posted: November 30, 2012
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Marc R Laufer, Boston Children's Hospital
  Purpose
In order to learn more about women's health issues that occur over the lifespan, the Women's Health Study: from Adolescence to Adulthood is building a biorepository and database. The biorepository collects, processes and stores samples (such as urine, saliva, blood, cells, tissue and peritoneal fluid) until they are needed for research. The database contains de-identified information about our study participants. The biorepository and database are being created to serve as a resource for researchers from Boston Children's Hospital, Brigham and Women's Hospital and outside institutions.

Condition
Pelvic Pain Endometriosis Dysmenorrhea Infertility

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Women's Health Study: From Adolescence to Adulthood Sponsored by the Boston Center for Endometriosis.

Resource links provided by NLM:


Further study details as provided by Marc R Laufer, Boston Children's Hospital:

Primary Outcome Measures:
  • Establishing a biorepository and database [ Time Frame: next 20 years ]

Biospecimen Retention:   Samples With DNA
urine, saliva, blood, tissue, peritoneal fluid

Estimated Enrollment: 2000
Study Start Date: November 2012
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females with endometriosis
Females with a surgical diagnosis of endometriosis or who undergoing surgery for suspected endometriosis. At this time, we are only recruiting patients of Boston Children's Hospital and Brigham and Women's Hospital for this group.
Females without surgical diagnosis of endometriosis
Females do not need to be patients of Boston Children's Hospital or Brigham and Women's Hospital.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
clinic and community sample
Criteria

Inclusion Criteria:

  • female
  • at least 7 years old
  • not experiencing natural menopause

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738204


Contacts
Contact: Jenny Sadler, MPH 617-355-7959 jenny.sadler@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jenny Sadler, MPH    617-355-7959    womenshealthstudy@childrens.harvard.edu   
Principal Investigator: Marc R Laufer, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cam Fraer, RN, BSN    617-732-4242    womenshealthstudy@partners.org   
Principal Investigator: Marc R Laufer, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Marc R Laufer, MD Boston Children’s Hospital
  More Information

Additional Information:
Responsible Party: Marc R Laufer, Chief, Division of Gynecology, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01738204     History of Changes
Other Study ID Numbers: IRB-P00004267
First Submitted: November 28, 2012
First Posted: November 30, 2012
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Marc R Laufer, Boston Children's Hospital:
women's health
endometriosis
dysmenorrhea
pelvic pain
adolescence
biorepository
observational
women
female
gynecology
fertility
infertility

Additional relevant MeSH terms:
Infertility
Endometriosis
Pelvic Pain
Dysmenorrhea
Genital Diseases, Male
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes