Status:
UNKNOWN
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Lead Sponsor:
The Jones Institute
Conditions:
Postpartum Depressive Mood
Postpartum Sexual Function
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, controlled cohort study. This study will look at the effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20 mcg/Norethindrone 1mg on postpartum...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18-45 year old women who desire contraception postpartum for at least 6 weeks.
- 18-45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group.
- Exclusion Criteria (Medication groups):
- Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population).
- Delivery by cesarean section.
- Previous history of depression, mood disorders, or psychiatric disorders.
- Any condition (history or presence of) which contraindicates the use of combination OCs, including:
- Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders.
- Pulmonary Embolism.
- Cerebrovascular or coronary artery disease or myocardial infarction.
- Diabetes mellitus.
- Migraine headaches with focal, neurological symptoms.
- Chronic renal disease.
- Uncontrolled or untreated hypertension.
- Cholestatic jaundice.
- Known or suspected carcinoma of the breast, endometrial carcinoma, or known or suspected estrogen-dependent neoplasia.
- Impaired liver function or disease, hepatic adenomas or carcinomas.
- Known hypersensitivity to estrogens and/or progestins.
- History of thyroid disorders.
- Recent alcohol or drug use.
- Smoking and age ≥35 or smokers who will become 35 years of age during the study.
- Known history of noncompliance with taking medication.
- Exclusion Criteria (Control group):
- Previous history of depression, mood disorders, or psychiatric disorders.
- Recent alcohol or drug use.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02210702
Start Date
July 1 2014
Last Update
August 7 2014
Active Locations (1)
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1
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507