Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)

NCT00927095 | Completed Phase 4 Results DMC

• 2 other identifiers: MH081837R01MH081837
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously (every day for three months) with the same low dose oral contraceptive given in an interrupted regimen (one week of inactive placebo pills each month) and with continuous placebo (inactive placebo given every day for three months). The primary hypothesis is that continuous OC will be significantly more effective in reducing premenstrual symptoms compared with either the interrupted OC or continuous placebo.

Conditions

Premenstrual Dysphoric Disorder

Keywords

PMDD; Oral contraceptives; steroid hormones; neurosteroids

Outcome Measures

Primary Outcomes (1)

• Pre-Post Change in Premenstrual Symptom Severity

  Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: "mean rating on the individual's worst symptom during the premenstrual week at baseline" minus "mean rating during the premenstrual week during the last on-treatment cycle". Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial.

  monthly

Study Arms (3)

Continuous OC (EE/DROS)

ACTIVE COMPARATOR

Continuous daily oral drospirenone (DROS; 3mg) + ethinyl estradiol (EE; 20ug)

Drug: Continuous OC (EE/DROS)

Intermittent OC (EE/DROS)

ACTIVE COMPARATOR

Interrupted (21 days active - 7 days placebo) oral DROS (20ug)/EE(3mg)

Drug: Intermittent OC (EE/DROS)

Placebo

PLACEBO COMPARATOR

Continuous daily oral placebo

Drug: placebo

Interventions

Continuous OC (EE/DROS) DRUG

Continuous EE(20ug)+DROS(3mg) daily for 3 months

Also known as: Yaz

Continuous OC (EE/DROS)

Intermittent OC (EE/DROS) DRUG

Intermittent EE(20ug)+DROS(3mg) daily for 21 days each month

Also known as: Yaz

Intermittent OC (EE/DROS)

placebo DRUG

daily placebo

Also known as: oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• meets prospective criteria for PMDD, AND
• English speaking and reading skills.

You may not qualify if:

• current psychiatric disorder other than PMDD,
• history of venous thromboembolism,
• over 35 years of age and obese,
• uncontrolled hypertension or end-organ vascular disease,
• diabetes,
• migraine headache with aura,
• breastfeeding or pregnant,
• cigarette smoking,
• family history of premenopausal breast cancer or breast cancer in more than one first degree relative,
• elevated serum potassium levels, use of prescription medications (except stable thyroid supplementation),
• irregular menstrual cycles, OR
• history of: endometriosis, hepatic disease, breast carcinoma, pulmonary embolism or phlebothrombosis, malignant melanoma, cholecystitis or pancreatitis.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Eisenlohr-Moul TA, Girdler SS, Johnson JL, Schmidt PJ, Rubinow DR. Treatment of premenstrual dysphoria with continuous versus intermittent dosing of oral contraceptives: Results of a three-arm randomized controlled trial. Depress Anxiety. 2017 Oct;34(10):908-917. doi: 10.1002/da.22673. Epub 2017 Jul 17.

  PMID: 28715852 DERIVED

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Susan Girdler
• Organization: University of North Carolina at Chapel Hill

susan_girdler@med.unc.edu

919-966-2179

Study Officials

• Susan Girdler, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 24, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 24, 2016
• Results First Posted: August 24, 2016

Record last verified: 2016-07

Locations

US (1)