Comparison of Dienogest versus Freedase in Endometriosis associated pain.

Comparison of Dienogest alone versus Dienogest and Ethinyl Estradiol for Endometriosis Pain Relief: an open label Randomized controlled Trial. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079591

Enrollment

110

Registered

2025-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: N809- Endometriosis, unspecified

Interventions

Intervention1: Tab.Dienogest: Oral Dienogest 2mg once dailuy for 84 days(12 weeks) + 84 days(12 weeks) Control Intervention1: Combination of Dienogest and Ethinyl estradiol: Oral tablet - Combination

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically, Histologically or Radiologically diagnosed endometriosis. 2. Presence of Pain symptoms associated with endometriosis like Dysmenorrhea, Dyspareunia or non-cyclical chronic pelvic pain. 3. Baseline VAS score for pain of more than or equal to 4 at time of enrollment.

Exclusion criteria

Exclusion criteria: 1. Current user of hormonal therapy or used within 2 months. 2. Presence of pregnancy, lactation or planning to conceive. 3. Previous history of failed improvement with the study medication. 4. History of drug reaction to steroid hormones or COC or Dienogest. 5. Contraindication for Estrogen and or Progesterone. 6. Planned for surgical treatment for endometriosis or other medical therapy. 7. Pain due to causes other than endometriosis. 8. Not willing to participate or not willing for follow up.

Design outcomes

Primary

Measure	Time frame
Change in the endometriosis associated pain assessed by Visual Analogue Score (VAS score) from the baseline.Timepoint: Baseline, 12 weeks and 24 weeks	—

Secondary

Measure	Time frame
Change in the Self-reported Pain symptoms (chronic pelvic pain, dysmenorrhea & dyspareunia) assessed by the Biberoglu & Behrman (B&B) scale. Improvement in the Health-related quality of life (HRQoL) after starting the treatment assessed by Endometriosis Health Profile - 30 (EHP-30) questionnaire Change in the mean diameter of ovarian endometrioma Comparison of safety & tolerability of either treatment.Timepoint: Baseline, 12 weeks & 24 weeks	—

Measure

Time frame

Change in the Self-reported Pain symptoms (chronic pelvic pain, dysmenorrhea & dyspareunia) assessed by the Biberoglu & Behrman (B&B) scale. Improvement in the Health-related quality of life (HRQoL) after starting the treatment assessed by Endometriosis Health Profile - 30 (EHP-30) questionnaire Change in the mean diameter of ovarian endometrioma Comparison of safety & tolerability of either treatment.Timepoint: Baseline, 12 weeks & 24 weeks

—

Countries

India

Contacts

Public ContactJENCY S

Christian Medical College, Vellore.

manpushp05@gmail.com9500359929

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026