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Trial record 68 of 190 for:    Postpartum Depression AND women | "Depression" AND "Depression"

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

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ClinicalTrials.gov Identifier: NCT02210702
Recruitment Status : Unknown
Verified August 2014 by The Jones Institute.
Recruitment status was:  Recruiting
First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
The Jones Institute

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.

Condition or disease Intervention/treatment Phase
Postpartum Depressive Mood Postpartum Sexual Function Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Study Start Date : July 2014
Estimated Primary Completion Date : January 2015


Arm Intervention/treatment
Experimental: Ethinyl Estradiol 35mcg/Noethindrone 1mg
21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg
Experimental: Ethinyl Estradiol 20mcg/Norethindrone 1mg
21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg
No Intervention: No hormonal contraception
Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. Time to First Coitus [ Time Frame: Time to first coitus during postpartum period ]
  2. Urine Pregnancy Test [ Time Frame: Week 6-7 Postpartum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210702


Contacts
Contact: Kelly McDaniel, MS mcdanik@evms.edu

Locations
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
The Jones Institute

Responsible Party: The Jones Institute
ClinicalTrials.gov Identifier: NCT02210702     History of Changes
Other Study ID Numbers: 14-06-FB-0118-HOSP
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Puerperal Disorders
Depressive Disorder
Contraceptive Agents, Female
Behavioral Symptoms
Pregnancy Complications
Mood Disorders
Mental Disorders
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Norethindrone
Norethindrone acetate
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptives, Oral, Synthetic