- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03106454
Ovulation Incidence in Oral Contraceptive Users
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Use of combined hormonal contraceptives (CHC) containing estrogen is associated with venous thromboembolic events. In an effort to decrease the risks of estrogen, the dose of ethinyl estradiol (EE) contained in combined oral contraceptive (COC) pills has decrease substantially from >100mcg to 20mcg. In 2012, a COC with only 10mcg of EE (Tradename LoLoestrin) was approved by the Food and Drug Administration. However, no studies have compared this formulation to pills containing progestin alone to determine if this very low dose of EE decreases ovulation or improves unscheduled uterine bleeding beyond what is seen with a progestin only pill (POP).
We aim to compare a COC with EE 10mcg/norethindrone (NET) acetate 1mg to a POP containing a nearly equal amount of progestin (norethindrone 1.05mg). The objective of the study is to compare the incidence of ovulation among users of a COC with only EE10mcg/NET acetate 1mg to users of a POP with a nearly identical progestin dose of NET 1.05mg. We plan to recruit 58 women between the ages of 18 and 45 years old, who are ovulatory at baseline based on serum progesterone levels. Subjects will be randomized to take either a COC containing EE 10mcg/NET acetate 1mg or a POP containing NET 1.05mg for one month. During the month of study treatment, we will measure ovulation incidence using a single serum progesterone levels of >=4.0ng/dl, sperm penetration of cervical mucus using the Eggert Kruse classification system, pill compliance by NET serum levels, and side effects including unscheduled uterine bleeding via subject daily diaries.
Our primary outcome, ovulation incidence, will be compared between study arms. Secondary outcomes will compare cervical mucus quality, sperm penetration of cervical mucus, side effects (including uterine bleeding), and pill compliance between users of these two pills.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Emily Silverstein, MPH
- Email: emilysil@usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90065
- Brian T. Nguyen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Reproductive aged women 18-45 years old.
- Menstrual cycle length 25-35days
- BMI less than or equal to 40
- English or Spanish speaking
Exclusion Criteria:
- Pregnant or breastfeeding in the previous 3 months.
- Use of OC, hormonal vaginal rings or patches, levonorgestrel containing intrauterine device, or etonogestrel implant in the previous 1 month. No use of depot medroxyprogesterone acetate (DMPA) injection in the previous 6 months and at least one menses since discontinuation.
- Medical contraindications to estrogen or progestin use. Specifically: smoking among participants over 35 years old, migraines with aura, history of blood clots, ischemic heart disease, stroke, breast cancer, cervical cancer, liver disease, symptomatic gallbladder disease, uncontrolled hypertension, antiphospholipid antibody syndrome, hyperlipidemia, diabetes with end organ damage (retinopathy, nephropathy, neuropathy) or diagnosis >20 years ago, organ transplant
- Desire to become pregnant in the next 4 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Combination oral contraceptive pill
Ethinyl Estradiol 10mcg/Norethindrone acetate 1mg/ferrous fumarate 75mg Taken cyclically as 24 tablets containing EE 10mcg/NET acetate 1mg 2 tablets of EE 10mcg only 2 tablets of ferrous fumarate 75mg
|
Combination Oral Contraceptive Pill.
Ethinyl Estradiol 10mcg/Norethindrone acetate 1mg/ferrous fumarate 75mg
Other Names:
|
Experimental: Progestin only pill
Norethindrone 0.35mg Marketed use for 1 tablet per day.
For study dosing, patients will take 3 tablets daily for a total of 1.05mg daily.
|
Norethindrone 1.05mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovulation
Time Frame: A single 28 day cycle
|
Ovulation based on a single serum progesterone level of 4ng/dl or greater
|
A single 28 day cycle
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sperm penetration of cervical mucus
Time Frame: A single 28 day cycle
|
The average distance sperm will travel in vitro in a test tube of cervical mucus collected from the participant.
|
A single 28 day cycle
|
Cervical mucus quality
Time Frame: A single 28 day cycle
|
Scoring of the ovulatory quality (thickness, cellularity, etc.) of cervical mucus collected from the participant
|
A single 28 day cycle
|
Side effects
Time Frame: A single 28 day cycle
|
Side effects self reported by the participant
|
A single 28 day cycle
|
Uterine bleeding
Time Frame: A single 28 day cycle
|
A daily calendar counting the number of days of uterine bleeding participants experience during the study cycle.
|
A single 28 day cycle
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pill complaince
Time Frame: A single 28 day cycle
|
Number of pills missed or forgotten over the course of a single 28 day cycle
|
A single 28 day cycle
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Brian T Nguyen, MD, MSc, University of Southern California
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Trace Elements
- Micronutrients
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Estradiol
- Ethinyl Estradiol
- Ferrous fumarate
- Norethindrone
- Norethindrone Acetate
Other Study ID Numbers
- HS-09-00669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contraception
-
Virginia Commonwealth UniversityCompletedPregnancy Related | Contraception | Contraception Behavior | Contraception Use
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Janssen Pharmaceutica N.V., BelgiumCompleted
-
Medical University of South CarolinaSociety of Family PlanningCompletedContraception | Contraception BehaviorUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedFemale Contraception | ContraceptionUnited States, Israel
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
University of California, San FranciscoAgency for Healthcare Research and Quality (AHRQ); Essential Access HealthNot yet recruitingContraception | Contraception Behavior | Reproductive BehaviorUnited States
Clinical Trials on Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate
-
University of OklahomaWithdrawn
-
University of Texas Southwestern Medical CenterCompleted
-
Bristol-Myers SquibbCompletedHealthy Female VolunteersUnited States
-
Bristol-Myers SquibbCompletedSystemic Lupus Erythematosus | Inflammatory Bowel Diseases | Psoriasis | Arthritic PsoriasisUnited States
-
Bristol-Myers SquibbCompletedRheumatoid ArthritisUnited States
-
Warner ChilcottCompleted
-
The Jones InstituteUnknownPostpartum Depressive Mood | Postpartum Sexual FunctionUnited States
-
Warner ChilcottCompleted
-
Teva Pharmaceuticals USACompletedBioequivalenceUnited States
-
Teva Pharmaceuticals USACompleted