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

Primary Purpose

Postpartum Depressive Mood, Postpartum Sexual Function

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ethinyl Estradiol 35mcg/Norethindrone 1mg
Ethinyl Estradiol 20mcg/Norethindrone 1mg
Sponsored by
The Jones Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depressive Mood

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sentara Norfolk General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Ethinyl Estradiol 35mcg/Noethindrone 1mg

Ethinyl Estradiol 20mcg/Norethindrone 1mg

No hormonal contraception

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum
Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum
Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum

Secondary Outcome Measures

Time to First Coitus
Urine Pregnancy Test

Full Information

First Posted
July 31, 2014
Last Updated
August 4, 2014
Sponsor
The Jones Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02210702
Brief Title
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Official Title
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Jones Institute

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depressive Mood, Postpartum Sexual Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ethinyl Estradiol 35mcg/Noethindrone 1mg
Arm Type
Experimental
Arm Description
21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Arm Title
Ethinyl Estradiol 20mcg/Norethindrone 1mg
Arm Type
Experimental
Arm Description
21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Arm Title
No hormonal contraception
Arm Type
No Intervention
Arm Description
Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).
Intervention Type
Drug
Intervention Name(s)
Ethinyl Estradiol 35mcg/Norethindrone 1mg
Intervention Type
Drug
Intervention Name(s)
Ethinyl Estradiol 20mcg/Norethindrone 1mg
Primary Outcome Measure Information:
Title
Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum
Time Frame
Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
Title
Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum
Time Frame
Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
Title
Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum
Time Frame
Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
Secondary Outcome Measure Information:
Title
Time to First Coitus
Time Frame
Time to first coitus during postpartum period
Title
Urine Pregnancy Test
Time Frame
Week 6-7 Postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly McDaniel, MS
Email
mcdanik@evms.edu
Facility Information:
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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