Trial record 2 of 29 for:
nichd Polycystic Ovary Syndrome (PCOS)
Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)
This study is currently recruiting participants.
Verified February 2013 by Yale University
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01070160
First received: February 16, 2010
Last updated: February 26, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.
| Condition | Intervention |
|---|---|
|
Polycystic Ovarian Syndrome |
Drug: Endometrin (progesterone 100mg vaginal inserts) Drug: Metformin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS) |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
- It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- blood draw (20mL) [ Time Frame: on day of EMBx ] [ Designated as safety issue: Yes ]
- A combination of quantitative real time PCR, immunohistochemistry, and Western Blot techniques will be utilized for studying endometrial markers of receptivity in the endometrial tissue [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood, endometrium tissue biopsy
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
Women with PCOS initiating Metformin and exposure to vaginal progesterone for 6-8 days prior ro Endometrium Biopsy
|
Drug: Endometrin (progesterone 100mg vaginal inserts)
once a day, 6-8 days as specified (prior to each EMBx)
Drug: Metformin
per clinical care guidelines
|
|
B
Women with PCOS not planning initiating Metformin and exposure to vaginal progesterone for 6-8 days prior to Endometrium Biopsy
|
Drug: Endometrin (progesterone 100mg vaginal inserts)
once a day, 6-8 days as specified (prior to each EMBx)
|
|
Women with PCOS who previously initiated metformin
Women with PCOS who initiated metformin at least 3 months prior to enrollment who have completed a 6-10 day course of progesterone
|
Detailed Description:
Endometrial assessments are proposed following three month and then nine month treatment with metformin; expression of specified markers at respective time points will be compared to baseline.
Visit 1: Screening
- Signed informed consent
- Comprehensive history intake
- Physical exam: Vital signs, height, weight, waist circumferences, waist : hip ratio
- Urine pregnancy test
- Subjects provided with a 10 day supply of vaginal progesterone and EMBx will be scheduled between days 6-8 of progesterone use.
Visit 2: Baseline
- Urine pregnancy test
- Endometrium thickness will be measured via transvaginal ultrasound
- EMBx: sample of endometrial tissue will be sent for histopathology to rule out endometrial hyperplasia or cancer
- 20cc blood
- Metformin prescription and dispensing will be as per clinical care.
- Women will be advised to use barrier method of contraception (ie; condoms, contraceptive jellies or foam, sponge, diaphragm, or cervical cap) for the duration of the study.
Visits 3 and 5 (Weeks 8-10 and 30-34, respectively)
- Urine pregnancy test
- A 10 day course of vaginal progesterone to allow scheduling of EMBx's time points specified under visit 1
Visits 4 and 6 (Weeks 12 ± 1 week and 36 ± 1 week respectively)
- The procedure specified for baseline (Visit 2) will be repeated.
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Women will be recruited from the multi-physician Yale Reproductive Endocrinology clinical practice and Yale Fertility Center. Metformin is a routinely employed therapeutic strategy utilized for managing PCOS by practitioners at YFC. Almost 1/3 of the patients with PCOS are not interested in pursuing fertility in the immediate future and it is these patients who will be offered participation in the trial.
Criteria
Inclusion Criteria:
- Premenopausal between 18-42 years of age
- Diagnosed with PCOS as defined by chronic oligo- or amenorrhea (8 menstrual periods annually); biochemical hyperandrogenemia (elevated total or free testosterone) and /or clinical hyperandrogenism (excessive facial hair &/or acne); exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone <200 ng/dl).
- Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months
- Able to provide signed informed consent
- Able to comply with study requirements
- Willing to delay the start of clinically prescribed metformin treatment
Exclusion Criteria:
- Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)
- Current use of hormonal contraceptives
- Seeking pregnancy; use of fertility drugs within 6 months of study
- Current or recent (within 3 months) use of metformin
- Ingestion of any investigational drug within two months prior to study onset
- Evidence of endometrial hyperplasia or cancer upon baseline EMBx
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070160
Contacts
| Contact: Lubna Pal, MBBS MRCOG MSc | (203)-737-5619 | lubna.pal@yale.edu |
| Contact: Joanne Williams, BSN | (203)-785-3463 | joanne.williams@yale.edu |
Locations
| United States, Connecticut | |
| Yale-New Haven Hospital Women's Center | Recruiting |
| New Haven, Connecticut, United States, 06520-8063 | |
| Contact: Lubna Pal, MBBS MRCOG MSc (203)-737-5619 lubna.pal@yale.edu | |
| Sub-Investigator: Hugh Taylor, MD | |
| Sub-Investigator: Beth Rackow, MD | |
| Sub-Investigator: Pinar Kodaman, MD/PhD | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Lubna Pal, MBBS MRCOG MSc | Yale University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01070160 History of Changes |
| Other Study ID Numbers: | U54 HD 052668-02, U54HD052668-02 |
| Study First Received: | February 16, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Polycystic Ovarian Syndrome (PCOS) Metformin Endometrin |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Adenoma Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Metformin Progesterone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013