Clinical Research Center: Past Clinical Trials

Past Clinical Trials

Menopause Studies

The Duramed Cenestin Hot Flash Study—was a trial of an investigational medication for generally healthy postmenopausal women aged 30-80 with or without a uterus who were naturally or surgically menopausal and who had moderate to severe hot flashes.
The Duramed Cenestin® hot flash study - A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin®) for the Treatment of Vasomotor Symptoms in postmenopausal women aged 30 to 80 years old. The purpose of this study was to demonstrate the safety and effectiveness of daily 0.3 mg synthetic conjugated estrogens, A (Cenestin®), in the reduction of frequency and severity of hot flashes in postmenopausal women by comparing it to placebo.
C31G Spermicide Study
Lime Juice Study - The Clinical Research Center at EVMS conducted a clinical research study of lime juice applied vaginally as a douche or with a pad. Participants were women between the ages of 18 and 50 with regular menstrual cycles who were also using birth control such as oral contraceptives or the patch, and not currently pregnant or breastfeeding.
Vaginal Atrophy Study - The Clinical Research Center at Eastern Virginia Medical School is currently seeking women ages 30 to 80 to participate in a research trial of a medication to relieve symptoms of vaginal weakening and dryness in postmenopausal women. To qualify for study participation, participants must have been between the ages of 30 and 80 years of age; naturally OR surgically menopausal (with OR without your uterus); and willing and able to complete study visits.
Hot Flash Study - The Clinical Research Center at Eastern Virginia Medical School sought postmenopausal women to participate in a research trial of a transdermal spray medication to relieve symptoms of hot flashes in postmenopausal women. To qualify for study participation, you must have been naturally OR surgically menopausal (with OR without your uterus), willing and able to complete study visits, and have at least eight moderate to severe hot flashes a day.
A Non-Hormonal Solution for Hot Flashes - We studied the non-hormonal compound Org 50081 as an alternative for the treatment of hot flashes. Although Org 50081 is not yet registered, the active ingredient of Org 50081 is one of the ingredients of mirtazapine, which is registered in many countries world-wide for another disease.

The purpose of this study was to evaluate the effects of four doses of Org 50081, an experimental drug similar to mirtazapine, on the frequency and severity of menopausal hot flashes and other menopausal symptoms (such as sleep disturbances and mood changes), and to compare these effects with those of a placebo treatment. We also evaluated the safety of the study drug.
A trial of EstroGel® in women aged 45 to 65 for the treatment of hot flashes and vaginal dryness. Participants had been without a menstrual cycle for at least 6 months, had a minimum of 7-8 moderate to severe hot flashes per day, did not have any known sensitivity to estrogen replacement therapy and were not pregnant or breastfeeding.
Clinical research trial evaluating an investigational sustained-release medication for relief of moderate to severe hot flashes in postmenopausal women.
16-week clinical trial evaluating the effects of currently-marketed hormone replacement therapies for healthy, postmenopausal women.
13-week clinical trial studying the effects that a new estrogen-releasing vaginal ring may have on hot flashes.
6-week clinical trial evaluating the effects Premarin may have on the production of tears in healthy women 45-80 years of age who have symptoms of dry, gritty, irritable, burning eyes.
A trial for post-menopausal women ages 42-80 who have been diagnosed with Type 2 diabetes to study the effects of hormone replacement therapies on triglyceride and lipoprotein levels.

Incontinence

3-month clinical trial of an experimental medication for urge incontinence and frequent urination in women ages 40 or older
12-week clinical trial to evaluate a new investigational drug for urinary incontinence in healthy men and women over the age of 18 who have been diagnosed with urinary frequency and have experienced strong and frequent urges for at least 3 months

Contraceptive

Chewable Birth Control Pill Study—clinical trial of an investigational chewable, spearmint-flavored birth control pill for generally healthy women aged 18 to 45 years old and in need of contraception.
Birth Control Pill-Nomac –This was a randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1/5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drospirenone (DRSP) and 30 mg ethinyl estradiol (EE). Subjects received one of two comparative treatments for 13 consecutive 28-day cycles. Primary objective was to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women ages 18-50 years.
Low-Dose Birth Control Pill - This was a multicenter, open-label trial to demonstrate the efficacy of a new regimen of a combination of a norethindrone acetate 1 mg/ethinyl estradiol 10mdg (NETA 1/EE 10). In this new regimen, NETA 1/EE 10 was administered daily for 24 days followed by 2 days of ethinyl estradiol 10 mcg (EE 10) and 2 days of a placebo tablet. Efficacy was determined by calculation of the Pearl Index and by life table methods. The treatment lasted for 13, 28-day cycles. The study also assessed the bleeding profile associated with this reduced dose and extended treatment regimen. The primary objective of the study was to assess the efficacy of the study drug in the prevention of pregnancy.
Birth Control Pill-NOMAC - A Phase III Clinical Trial comparing two 28-day cycle birth control pills to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years. Secondary objectives: To evaluate the effects of the NOMAC-E2 COC on satisfaction and health related quality of life, libido, acne, menstrual symptoms, and body weight; to explore the aforementioned characteristics of the NOMAC-E2 COC in comparison with the DRSP-EE COC.
Low-Dose Birth Control Pill - A Phase III Clinical Trial to demonstrate the efficacy of a new regimen of a combination of norethindrone acetate 1 mg/ethinyl estradiol 10 mcg (NETA 1/EE 10). The study also assessed the bleeding profile associated with this reduced dose and extended treatment regimen. The primary objective of the study is to assess the efficacy of WC3016 in the prevention of pregnancy in women 18 to 45 years old at risk of becoming pregnant.
BufferGel Duet Study - The Clinical Research Center at EVMS conducted a study of the BufferGel Duet, a new diaphragm-like device which was tested with BufferGel (an investigational drug). This was the first research study using the BufferGel Duet. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA). The BufferGel Duet is made of polyurethane (like thick rubber) and comes in one size. It is coated on both sides with BufferGel (a gel that may kill sperm and may also kill some microorganisms that may cause sexually transmitted infections [STIs], like HIV). The Duet is designed to spread the gel to most areas of the vagina when it is inserted. It fits inside your vagina and is held in place by a thick, flexible rim. The Duet covers the cervix (opening to the womb) to block the entrance of sperm. The reason for combining BufferGel with a device is that a device that covers the cervix will likely increase protection against STIs/HIV and pregnancy, compared with the gel alone. The Duet could also serve as an applicator and spread the gel, and possibly help remove extra gel when it is taken out.
Birth Control Pill with Natural Estradiol - The Clinical Research Center at EVMS conducted a research study of a combination oral contraceptive using natural estrogens. The purpose of the study was to show that the study drug was safe and effective in preventing pregnancy. The study medication SH T00658ID (EV/DNG tablet) was considered an investigational drug because the Food and Drug Administration (FDA) has not yet approved it as a treatment for birth control. The study medication SH T00658ID (EV/DNG tablet) is a new combined oral contraceptive. The active substances are the natural estrogen estradiol valerate (EV), and the progestogen dienogest (DNG).
Healthy women ages 18-40 took part in a clinical research study evaluating the safety and effectiveness of a new spermicide used with a diaphragm. Participation in the study required that volunteers be in a monogamous relationship, have regular menstrual cycles and be willing to use the test product as their only method of birth control for the duration of the study (6 months).
Clinical research trial of two currently marketed products conducted at the Clinical Research Center at Eastern Virginia Medical School. Women aged 40-48 with regular menstrual cycles participated to determine the effects of the study drugs on cycle control.
Clinical research trial of a new birth control pill.
Clinical trial comparing use of different doses of oral contraceptive as emergency contraception within 72 hours of condom slippage, breaking, or other "accident."
Clinical trial of the effect of low-dose oral contraceptives on the endometrium involving women ages 18 - 40
15-day clinical trial of a marketed female condom
Research study comparing different doses of a spermicide
Questionnaire to study spermicide use
Research study regarding a new contraceptive patch
8-week trial of a new reusable birth control device with 60 sexually active women between the ages of 18 and 40
7-month clinical trial with 100 women between the ages of 18 and 35, comparing the effectiveness of different marketed forms of spermicides
14-month clinical trial of an experimental birth control pill, with women 18-39 with regular menstrual cycles
7-month clinical trial comparing a currently marketed oral contraceptive pill to an experimental oral contraceptive, with healthy women ages 18 and older, with regular menstrual cycles and are who not at risk for pregnancy
Clinical trial for a newly designed diaphragm device, with women 18 to 45 who have had a tubal ligation and have regular cycles
5-year clinical research study to demonstrate the safety and effectiveness of a new device that provides permanent contraception
Contraceptive research study involving the use of an intrauterine system for 12 months in women 18-45 years old
Healthy females participated in a 7-month research study of various marketed spermicide contraceptives and condoms
13-month clinical trial involving women ages 18-40 to evaluate the safety and effectiveness of a new birth control pill
A 5-month clinical research trial of a birth control pill involving healthy women ages 18-35 with regular cycles.
Birth Control Pill Study - 8 month long birth control pill study for healthy women ages 18 to 35 with regular cycles.
Emergency Contraception - Study of different doses of currently marketed birth control to determine possible use for "Contraceptive Accidents" (i.e., a tear or slippage in a condom, diaphragm not inserted properly, etc.) within 72 hours of an unprotected sex act. Study included women 18 years and older.
Silcs Diaphragm Study - Safety and efficacy study evaluating use of the Silcs diaphragm in healthy women ages 18-45.
UC-781 Gel Study - 1 month clinical trial of the UC-781 vaginal gel in sexually abstinent women 18-50 years of age.
Microbicide Gel Study - 1 month clinical trial of a new vaginal gel with potential microbicidal properties in women 18-50 years of age.

Other Types of Clinical Trials

Vaginal Gel Study—This study was an assessment of markers of inflammation after vaginal product use. The purpose of the study was to characterize inflammation and genital epithelial changes in healthy, sexually abstinent women before, during, and after 5/12 days of twice-daily application of a hydroxyethylcellulose (HEC)- based “universal” placebo or 4% nonoxynol-9 gel; to determine the degree of correlation between different methods of clinical assessment; and to determine the degree of correlation between the results of this clinical study and the results of the preclinical assessment of the same compounds.
Perm Study for Men: Effects of long-term use of ORACEAä (doxycycline, UPS) 40 mg on human sperm motility and morphology. The main purpose of this study was to find out if the use of ORACEA in a low, non-therapeutic dose had any effect on the quality and quantity of sperm production in healthy men ages 18 to 45 years old.
TAMS Study for Menorrhagia - A Long Term, Open Label, Multicenter Study to Evaluate the Safety of a 1.3 g Oral Dose of a New Modified-Release Tranexamic Acid Formulation Administered Three Times Daily for up to 5 Days During The Menstrual Cycle in Women with Heavy Menstrual Bleeding Associated with Menorrhagia. The purpose of the study was to evaluate the safety of XP12B-MR in women with menorrhagia (regular periods with heavy bleeding) and its effect on quality of life (QOL) and a subgroup to test a newly developed questionnaire and menstrual diary that could be used in future studies involving women with heavy menstrual bleeding.
Vaginal Gel Study - Tolerance and Safety Study of V-Gel Microbicide in women 18 to 45 years of age with regular menstrual cycles of 23-28 days. The purpose of this study was to evaluate the signs/symptoms of burning or irritation of the V-Gel product in the vagina while the patient is observed in the clinic. The product is designed to maintain vaginal conditions, such as acidity, that promote vaginal health.
Endometriosis Study - This research study was designed to see if a new form of Danazol, the Danazol vaginal ring is effective and safe for endometriosis-related pain. Danazol is FDA-approved in pill form for the treatment of endometriosis, but is investigational as a vaginal ring. “Investigational” means the drug has not been approved by the United States Food and Drug Administration (FDA). This study also helps identify any side effects related to using the Danazol vaginal ring. Results of this study provide information for creating other studies using the Danazol vaginal ring to treat endometriosis-related symptoms.
A clinical trial of different vaginal gels used in combination with a diaphragm for healthy women aged 18-48 who were NOT at risk for pregnancy.
A clinical research trial to determine the possible benefit of a common antibiotic (doxycycline) on the reduction of irregular menstrual bleeding noted in some previous Norplant users.
Clinical research trial investigating the effects of a hormone patch on the ovary.
Clinical research trial for women 18-50 years of age who are willing to be sexually abstinent for 14 days while using a vaginal gel.
Another clinical research trial for women 18-50 years of age who are willing to be sexually abstinent for 14 days while using a vaginal gel.
Clinical research trial of a vaginal ring delivering a study medication (Metronidazole) for women 18-55 who had problems with vaginal discharge with an unpleasant odor.
6-month clinical trial evaluating an investigational medication for women with symptoms of Polycystic Ovary Syndrome
Research trial concerning Type II diabetes
12-week clinical research study evaluating an investigational medication for symptoms of overactive bladder
An investigational clinical research study that will evaluate the effectiveness of a procedure typically performed during gynecological examinations, with women 18-45 in good health, using a reliable form of birth control and having regular menstrual cycles
A 12-week clinical research study evaluating an investigational medication for symptoms of overactive bladder in men and women
Clinical research trial of a vaginal ring delivering a study medication (Metronidazole) for women 18-55 who had problems with vaginal discharge with an unpleasant odor.
Clinical research trial for women 18-50 years of age who are willing to be sexually abstinent for 14 days while using a vaginal gel.
Another clinical research trial for women 18-50 years of age who are willing to be sexually abstinent for 14 days while using a vaginal gel.
Clinical research trial investigating the effects of a hormone patch on the ovary.

Dysmenorrhea Study

6-month clinical trail to determine the effect a marketed birth control pill has on the symptoms of menstrual cramping.