Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery

The University of Hong Kong (HKU)

Status and phase: Unknown; Phase 4

Conditions: Endometriosis

Treatments: Drug: Dienogest; Drug: Microgynon

Study type: Interventional

Funder types: Other

Identifiers

NCT02385448

UW 14-097

Details and patient eligibility

About

The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Good general health
• Older than the age of legal consent (i.e. 18 years old)
• Sonographic diagnosis of ovarian endometrioma with diameter at least 4cm on 2 separate scans at least 6 weeks apart
• No contraindication to use of progesterone or combined oral contraceptive pills
• Not attempting to conceive either at the time of study entry or for at least 2 years after surgery
• Willing and able to participate after the study has been explained

Exclusion criteria

• Operative findings not suggestive of endometriotic cyst
• Contraindications to progestogens or oral contraceptive pills
• Unwillingness to tolerate menstrual irregularity
• Planning pregnancy within 2 years of study
• Cannot understand English, Cantonese or Putonghua

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

144 participants in 2 patient groups

Dienogest

Experimental group

Treatment:

Drug: Dienogest

Combined oral contraceptive pills

Active Comparator group

Treatment:

Drug: Microgynon