Research, Studies & Clinical Trials

Mirena Extended Trial

Full Title Multi-center, open-label, uncontrolled study to assess contraceptive efficacy and safety of Mirena during extended use beyond 5 years in women 18 to 35 years of age including a subgroup evaluation of treatment effect on heavy menstrual bleeding.
Short Title Mirena Extended Trial (MET)
COMIRB # Western IRB – 16-2326
Description The purpose of the study is to evaluate the use of Mirena beyond 5 years up to 8 years of use for effectiveness at preventing a pregnancy, assessing bleeding patterns, and safety during extended use.
Who is eligible Women between 18-33 years old, currently using Mirena for at least 4 years and 6 months.
Compensation provided Yes
Primary Investigator Dr. Stephanie Teal
Sponsor Bayer Healthcare
Contact Rebecca Seale, email or call 303-724-2013

 

Non-Hormonal Birth Control: Studying two different types of Copper IUDs

Full Title A multi-center, single-blind, randomized clinical trial to compare two copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
Short Title Non-hormonal birth control: studying two different types of copper IUDs
COMIRB # Chesapeake IRB – 17-0225
Description Study of two copper IUDs: One which is FDA approved, ParaGard, and another which is approved and used in Europe, Mona Lisa.
Who is eligible Women between the ages of 18-40 who pass clinical lab criteria.
Compensation provided Yes
Primary Investigator Dr. Stephanie Teal
Sponsor FHI 360 & NIH
Contact Ines Crato, email or call 303-724-5559

 

Research about the Effects of Your Genetics on the Contraceptive Implant (Nexplanon®)

Full Title The pharmacogenomics of contraception: genetic determinants of etonogestrel pharmacokinetics.
Short Title Pharmacogenomics-Implant
COMIRB # 16-2462
Description To research how genetic differences effect how well contraceptives work, specifically the contraceptive implant. The study visit takes approximately 30 minutes. You will complete a brief questionnaire and blood will be drawn.
Who is eligible Are you a healthy woman between the ages of 18-45? Do you currently have the birth control implant (Nexplanon®) and have had it for the last 1 to 3 years?
Compensation provided Yes
Primary Investigator Dr. Aaron Lazorwitz
Sponsor The Society of Family Planning
Contact Rebecca Seale, email or call 303-724-2013

 

Research about the Effect of Isotretinoin (acne medication) on the Etonogestrel Contraceptive Implant (Implanon®/Nexplanon®)

Full Title The effect of isotretinoin on the etonogestrel contraceptive implant.
Short Title Isotretinoin-Implant
COMIRB # 16-0614
Description  Participation will last up to 20 weeks. Blood will be drawn at the beginning of the study and at two subsequent study visits: 4 and 9 weeks after enrollment. You will be called 20 weeks after enrollment for a brief telephone interview. You must have a birth control implant in place to qualify for the study.
Who is eligible Are you a healthy woman between the ages of 18-45? Are you currently under the care of a Dermatologist and considering starting treatment with isotretinoin (Accutane®)? Do you currently have the birth control implant (Implanon®/Nexplanon®) or are you planning to use the birth control implant during isotretinoin (Accutane®) therapy?
Compensation provided Yes
Primary Investigator Dr. Aaron Lazorwitz
Sponsor None
Contact Rebecca Seale, email or call 303-724-2013

 

Fertility patch study for women who have never had a menstrual period

Full Title A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered via OmniPod Pump for Ovulation Induction in Female Subjects with Primary Amenorrhea with Hypogonadotropic Hypogonadism
Short Title LutrePulse OmniPod Hypo Hypo Study
COMIRB # Western IRB – 13-352
Description Study of a possible fertility patch for women who are hypo hypo (never had a menstrual period)
Who is eligible Women with Hypo Hypo who pass clinical lab criteria.
Compensation provided Yes
Primary Investigator Dr. Nanette Santoro
Sponsor Ferring Pharmaceuticals
Contact Celeste Robledo, email or call 303-724-2013

 

Are you stopping your birth control because you want to become pregnant?

Full Title Fertility After Contraceptive Termination: The FACT Study
Short Title FACT
COMIRB # 13-1594
Description Examine conception rates after contraception termination
Who is eligible Women 18-35 who are planning to, or have recently stopped their birth control because they want to become pregnant.
Compensation provided Yes
Primary Investigator Dr. Stephanie Teal
Sponsor Washington University, St. Louis
Contact Sandra Cano, email or call 303-724-2013

 

Bothersome Bleeding while using Implanon or Nexplanon

Full Title Does concomitant use of combined oral hormonal steroids stop bleeding in women using etonogestrel implants (Implanon/Nexplanon)?: A randomized controlled study
Short Title Implant Bleeding
COMIRB # 13-1702
Description Study on a potential treatment for bothersome bleeding/spotting related to the etonogestrel implant.
Who is eligible Women 18-44 who are experiencing bothersome bleeding/spotting while using Implanon or Nexplanon
Compensation provided Yes
Primary Investigator Dr. Maryam Guiahi
Sponsor American College of Obstetricians & Gynecologists and Ferring Pharmaceutical Inc. Research Fellowship in Menstrual Bleeding Disorders
Contact Sandra Cano, email or call 303-724-2013

 

Birth Control Hormone Therapy for Perimenopause Treatment Research Study

Full Title Effectiveness of Perimenopausal Hormone Therapy in Suppression of Ovulation, Stabilization of Reproductive Hormones, and Symptom Control
Short Title Bayer-Perimenopausal
COMIRB # 11-1711
Description Study to determine effectiveness of perimenopausal hormone therapy (Mirena intrauterine device alone and in conjunction with estradiol gel) in suppression of ovulation, stabilization of reproductive hormones, and symptom relief in perimenopausal women
Who is eligible Women ages 40–52 with regular periods and any of the following symptoms of perimenopause

  • Hot flashes
  • Cyclical bloating, mood changes or headache
  • Trouble sleeping
Compensation provided Yes
Primary Investigator Dr. Nanette Santoro
Sponsor Bayer Corporation
Contact Christina Gavito, email or call 303-501-4157

 

 Contact Our Research Staff 

Our Research Staff

Family Planning research staff

Email: [email protected]

Study Cell 1: (303) 501-4157

Study Cell 2: (720) 505-7413


OB/GYN research staff