Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

NCT06145438 | Completed Phase 3

• 1 other identifier: 00000088
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question\[s\] it aims to answer are:

1. 1.Health-related quality of life (HRQoL)
2. 2.VAS score
3. 3.Beta estradiol
4. 4.TNF Alpha
5. 5.Adnexal mass recurrence
6. 6.Leuprolide Acetate injection/month
7. 7.Dienogest 2 mg/day
8. 8.COC (mycrogynon)/day
9. 9.DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

Conditions

Endometriosis Ovary

Outcome Measures

Primary Outcomes (2)

• beta estradiol level

  Measuring beta estradiol level on the serum

  0 and 12 weeks of treatment

• TNF alpha level

  Measuring TNF alpha level on the serum

  0 and 12 weeks of treatment

Secondary Outcomes (3)

• VAS score

  0 and 12 weeks of treatment

• health-related quality of life (HRQoL)

  0 and 12 weeks of treatment

• Mass recurrence

  0 and 12 weeks of treatment

Study Arms (4)

Leuprolide Acetate

ACTIVE COMPARATOR

Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months

Drug: Leuprolide (as Leuprolide Acetate)

Dienogest

EXPERIMENTAL

Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months

Drug: Dienogest

Depot medroxyprogesterone acetate

EXPERIMENTAL

Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months

Drug: Depo Medroxyprogesterone acetate

Combined Oral Contraceptive

EXPERIMENTAL

Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months

Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)

Interventions

Dienogest DRUG

Drug is administered orally at the same time every day

Also known as: Nelandoz

Dienogest

Depo Medroxyprogesterone acetate DRUG

Drug is injected intramuscularly on the buttock

Also known as: Depo Provera

Depot medroxyprogesterone acetate

Leuprolide (as Leuprolide Acetate) DRUG

Drug is injected intramuscularly on the buttock

Also known as: Tapros

Leuprolide Acetate

Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon) DRUG

Drug is administered orally at the same time every day

Also known as: Combined oral contraceptive

Combined Oral Contraceptive

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient post surgical removal of endometriosis cyst Willing to participate

You may not qualify if:

• Use of any hormonal therapy for endometriosis within the previous 16 weeks.
• History of severe adverse drug reactions or hypersensitivity to steroid hormones.
• Failure of previous treatment with COC, DMPA used in this study.
• There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
• Smoker.

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (1)

Kariadi Hospital

Semarang, Central Java, 50244, Indonesia

Location

MeSH Terms

Interventions

dienogest; Medroxyprogesterone Acetate; Leuprolide; Ethinyl Estradiol; Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Yuli Trisetiyono, SpOG (K)

  Diponegoro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 24, 2023
• Study Start: September 4, 2023
• Primary Completion: August 19, 2024
• Study Completion: November 19, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Starting in March 2024
• Access Criteria: Informed Consent Form will be shared to other researchers by sending email

Locations

ID (1)