Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales

The Jones Institute

Status and phase: Unknown; Phase 4

Conditions: Postpartum Sexual Function; Postpartum Depressive Mood

Treatments: Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg; Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02210702

14-06-FB-0118-HOSP

Details and patient eligibility

About

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 depressive symptoms and sexual function scores when compared to a control group using no hormonal contraception. Depressive symptoms and sexual function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W). Participants will begin taking the medication at Week 3 postpartum, and these outcomes will be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and increase in sexual function in both of the oral contraceptive groups.

Enrollment: 33 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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33 participants in 3 patient groups

Ethinyl Estradiol 35mcg/Noethindrone 1mg

Experimental group

Description:

21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum

Treatment:

Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg

Ethinyl Estradiol 20mcg/Norethindrone 1mg

Experimental group

Description:

21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum

Treatment:

Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg

No hormonal contraception

No Intervention group

Description:

Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).