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Oxidative Damage and Premature Rupture of the Membranes
Principal Investigator: |
Dr. James R. Woods, Jr., MD. Co PI: Richard K. Miller, Ph.D |
Purpose: |
To determine if vitamins C and E taken after Premature Rupture of Membranes (PROM) may help to strengthen the chorioamnion and delay the onset of premature delivery. |
Inclusion Criteria: |
- Pregnant women between 24-34 weeks with PROM, less than 2 cm dilated, no symptoms of PTL or evidence of infection. No vaginal bleeding.
- Women with Preterm labor- documented contractions refractory to intravenous fluids and which tocolytic medications are needed; 24-34 weeks, no evidence of infection; cervic dilated less than 4 cm, no evidence of PROM. Positive fetal fibronectin in vaginal secretions.
- Control group - normal healthy pregnant women between 24-34 weeks with no evidence of PROM , PTL or chorioamnionitis.
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Enrollment: |
43 patients from each group per year |
Contact: |
Deb Pittinaro RN, MS, NP, Study Coordinator. 585-275-1608 |
Pulsitile vs Continuous Growth in the Human Fetus
Principal Investigator: |
Gordon Fry, MD |
Purpose: |
To determine if the fetus grows on a continous basis, or whether growth is pulsatile in nature. |
Inclusion Criteria: |
Healthy pregnant women between 26-29 weeks with no history of alcohol, drug or tobacco ouse, normal glucola, no medical problems, normal body weight at conception with appropriate weight gain during pregnancy, no fetal anomalies, singleton pregnancy, over 18 years of age. |
Enrollment: |
20 subjects. |
Contact: |
Deb Pittinaro RN, MS, NP, Study Coordinator. 585-275-1608 |
Vulvar Vestibulitis: Study the Clinical Efficacy of Four Medical Treatments
Principal Investigator: |
David Foster MD, MPH |
Sponsor: |
NIH |
Purpose: |
To study the clinical efficacy of four medical treatments for vulvar vestibulitis: topical lidocaine, oral desipramine, combined lidocaine and desipramine, and placebo cream and tablets. |
Inclusion Criteria: |
- Age range of female volunteers will be equal to or greater than 18 up to and including 50 years of age.
- Candidates must report greater than three continuous months' duration of vulvar symptoms of insertional dyspareunia, pain with tampon insertion, or pain to touch.
- The candidate should not demonstrate any other specific neuropathology.
- Pre-randomization laboratory testing should fail to identify atrophic vaginitis, dermatitis such as vulvar dystrophy, or pathogens such as fungus or herpes.
- Candidates will need to be capable of keeping adequate records and demonstrate reliability in use of medication.
- If the patient is premenopausal, adequate contraception will be necessary including oral contraceptives, barrier method, progestational contraceptives, vasectomy, tubal ligation, and hysterectomy.
- If the candidate is menopausal, hormone replacement will NOT be an inclusion/exclusion criterion, in the absence of visible atrophy or parabasal cells.
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Enrollment: |
128 women |
Contact: |
Merrill Kotok RNC, Study Coordinator. 585-275-7919 |
Lunelle™ for Self-Injection at Home: A Prospective Pre-Post Design Trial
Principal Investigator: |
Nancy Stanwood, MD |
Sponsor: |
Pfizer |
Purpose: |
If by teaching the subject to give themselves the shot, can they do it at home correctly? Also, to see if they like getting the injection at home and if it saves them time and money |
Inclusion Criteria: |
Subjects who are currently using Lunelle™, have ever used Lunelle™, or wish to use Lunelle™ |
Procedures: |
In-office and at home monthly injections, surveys, follow-up phone calls |
Enrollment: |
30 |
Location: |
AC5 |
Contact: |
Alison Carletta, RN. 585-273-3788 |
Urine Loss and Prolapse in Nulliparous Postmenopausal Women and Their Parous Sisters
Principal Investigator: |
Gunnhilde Buchsbaum MD |
Sponsor: |
NIH |
Purpose: |
To determine whether familial factors or vaginal delivery play a role in development of urine loss or protrusion of parts of the vagina or the uterus (prolapse) |
Inclusion Criteria: |
Post-menopausal biological sisters where one has had at least one vaginal delivery and the other has had no births |
Procedures: |
Visit 1 = routine GYN exam, questionnaire, pad test, voiding diary, bladder ultrasound
Visit 2 = urodynamics |
Location: |
AC5 |
Contact: |
Mare Perevich RN, BSN, CCRC, Research Coordinator. 585-273-2996 |
Gabapentin vs. Estrogen for the Treatment of Hot Flashes
Principal Investigator: |
Sireesha Reddy, MD |
Sponsor: |
NIH |
Purpose: |
To compare the effectiveness of gabapentin to estrogen and placebo in reducing hot flashes and other menopausal symptoms |
Inclusion Criteria: |
Post-menopausal women between 35-60 years old that experience 7-20 moderate-severe hot flashes/day, may be currently taking medication for hot flashes but will be washed-out for 4 weeks before randomization |
Procedures: |
Complete a daily hot flash diary, take daily study medication, blood draws, physical exam (over 5-6 visits) |
Enrollment: |
60 |
Location: |
4-3400 |
Contact: |
Cindy Capadano, Research Coordinator. 585-275-6044 |
Oral Contraceptives versus Depot-Leuprolide taken after Surgery for Endometriosis-Associated Pelvic Pain
Principal Investigator: |
David Guzick, M.D., Ph.D. Co-PI's Fred Howard, M.D., MS, Sara Sukalich, M.D. |
Sponsor: |
NIH |
Purpose: |
The specific aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the postoperative treatment of endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have undergone laparoscopic treatment for endometriosis. |
Inclusion Criteria: |
- Age greater than 18 and pre-menopausal.
- Pelvic pain of at least 3 months duration.
- Diagnosis of endometriosis by laparoscopy within two months of entry into the study. Diagnosis of endometriosis by either histology consistent with endometriosis or photographic evidence of lesions consistent with endometriosis
- Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale 40 of 5 or more for three or more months).
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Procedures: |
Subjects must be consented prior to surgery. If surgery results in diagnosis of endometriosis then patient is randomized into one of two groups. Subject is to complete study questionnaires, study medication, and attend 7 clinic visits over 12-14 months. |
Enrollment: |
194 subjects |
Contact: |
Maureen Nealon, Study Coordinator 585-273-5734 |
Adolescent Polycystic Ovary Syndrome (PCOS) - Metabolic Impact Study
Principal Investigator: |
Kathleen Hoeger, MD |
Purpose: |
To assess the metaboloic impact of intensive lifestyle modification, oral contracepitves, metformin and placebo on symptoms of PCOS. |
Inclusion Criteria: |
- Adolescent girls, ages 12-18.
- Overweight with an irregular menstrual cycle.
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Enrollment: |
40 adolescent girls are being recruited for this pilot study. |
Contact: |
Lynda Kochman, RN, CCRC, Study Coordinator, 585-273- 2995 |
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