Phase 4
Completed N=67
Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Source: ClinicalTrials.gov NCT00927095 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Pre-Post Change in Premenstrual Symptom Severity — 1.93; 1.73; 1.64 units on a scale
◆ Published Evidence
Established
41citations · ~5 / year
Treatment of premenstrual dysphoria with continuous versus intermittent dosing of oral contraceptives: Results of a three-arm randomized controlled trial.
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.
Linked Publications
-
Treatment of premenstrual dysphoria with continuous versus intermittent dosing of oral contraceptives: Results of a three-arm randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-Post Change in Premenstrual Symptom Severity |
1.93; 1.73; 1.64 | — |
Eligibility Criteria
Inclusion Criteria
- meets prospective criteria for PMDD, AND
- English speaking and reading skills.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00927095) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.