Zoely vs. Zoloft in Premenstrual Dysphoric Disorder

A randomised double-blinded interventional pilot of Zoely and Zoloft to treat Premenstrual Dysphoric Disorder

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000496617

Enrollment

Registered

2023-05-15

Start date

2024-05-07

Completion date

2026-02-03

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

PMDD is a common condition that causes significant distress and disruption to daily life. The treatment options for PMDD are limited, however, newer forms of COCPs are becoming available and investigation of its efficacy is urgently needed. Moreover, no study to date has directly compared the efficacy of the first-line treatment options for PMDD. The proposed study aims to investigate whether nomegestrol acetate/17-beta estradiol (Zoely) or sertraline (Zoloft) is more effective in reducing symptoms of PMDD.

Interventions

Arm 1 : Sertraline 100mg oral tablet daily for 3 months or Arm 2: Nomegestrol acetate (2.5mg) and 17-beta estradiol (1.5mg) (Zoely) oral tablet daily for 3 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Women of reproductive age (18-50 years) with regular menstrual cycles who: 1. Meet the DSM-5 diagnostic criteria for PMDD 2. Report at least one-year history of regularly experiencing PMDD symptoms, with sudden onset and sudden offset of depressive symptoms. This may or may not directly coincide with the luteal phase 3. Must use appropriate barrier contraception precaution 4. Demonstrated capacity to give informed consent

Exclusion criteria

Women who are: 1. Unable to provide informed consent 2. Women taking the OCP, using a hormonal intrauterine device (IUD) or contraceptive implant (Implanon) 3. Known history of estrogen dependent cancers (individual) 4. Contraindications to estradiol 5. History of blood clots (e.g., deep vein thrombosis, pulmonary embolism) 6. Clinical evidence of acute delirium or severe head injury 7. Presenting with ongoing, acute clinically-significant risk of suicide, as determined by PI (psychiatrist) on the basis of clinical assessment 8. Lifetime diagnosis of schizophrenia, schizoaffective disorder, substance-induced psychotic disorder or bipolar I disorder 9. Substance dependence requiring intervention or rehabilitation in the last 3 months 10. Currently pregnant or breastfeeding

Outcome results