Postpartum Depressive MoodPhase 4NCT02210702
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
A Phase 4 study testing Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20mcg/Norethindrone 1mg in people with Postpartum Depressive Mood and Postpartum Sexual Function, run by The Jones Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depressive Mood, Postpartum Sexual Function
- What is being tested?
- Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20mcg/Norethindrone 1mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Previous history of depression, mood disorders, or psychiatric disorders.
- Recent alcohol or drug use.
Trial locations and contacts
1 site in 1 country.
Kelly McDaniel, MS contact
United States1 site, 1 recruiting
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
About this study
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.
- Being tested
- Ethinyl Estradiol 35mcg/Norethindrone 1mg, Ethinyl Estradiol 20mcg/Norethindrone 1mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl Estradiol 35mcg/Norethindrone 1mgDrug
Ethinyl Estradiol 20mcg/Norethindrone 1mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Ethinyl Estradiol 35mcg/Noethindrone 1mg | Experimental | 21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum Receives: Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg |
| Ethinyl Estradiol 20mcg/Norethindrone 1mg | Experimental | 21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum Receives: Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg |
| No hormonal contraception | No intervention | Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum
Measured: Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum
Measured: Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum
Measured: Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
Secondary outcomes (2)
Time to First Coitus
Measured: Time to first coitus during postpartum period
Urine Pregnancy Test
Measured: Week 6-7 Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depressive MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jones Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210702
- Sponsor's protocol ID
- 14-06-FB-0118-HOSP
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
- ClinicalTrials.gov ID
- NCT02210702
- Acronym / sponsor ID
- 14-06-FB-0118-HOSP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The Jones InstituteUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ethinyl Estradiol 35mcg/Noethindrone 1mg | Experimental | Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum |
| Ethinyl Estradiol 20mcg/Norethindrone 1mg | Experimental | Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum |
| No hormonal contraception | No intervention | –Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethinyl Estradiol 35mcg/Norethindrone 1mg | Drug | Ethinyl Estradiol 35mcg/Noethindrone 1mg |
| Ethinyl Estradiol 20mcg/Norethindrone 1mg | Drug | Ethinyl Estradiol 20mcg/Norethindrone 1mg |
Primary outcome
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
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
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
2 secondary outcomes
Time to First Coitus
Time frame: Time to first coitus during postpartum period
Urine Pregnancy Test
Time frame: Week 6-7 Postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly McDaniel, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20mcg/Norethindrone 1mg in people with Postpartum Depressive Mood and Postpartum Sexual Function, run by The Jones Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly McDaniel, MS (mcdanik@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.