Randomized Study of Letrozole and Trilostane for Medical Abortion

Kristina Gemzell Danielsson

Status and phase: Terminated; Phase 2

Conditions: Medical Abortion, Complete or Unspecified, Without Complication

Treatments: Drug: Trilostane; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT01615211

W300TL

Details and patient eligibility

About

In menstruation an effective shedding of the endometrial lining occurs. Both progesterone and estrogen levels fall sharply at this time. During medical abortion the endometrial shedding is sometimes ineffective causing an incomplete abortion which may cause prolonged bleeding or require surgical intervention. In medical abortion a progesterone antagonist is used as treatment but the estrogen levels are not targeted. The investigators wish to explore whether addition of letrozole or trilostane which target estrogen levels can lead to a more effective shedding of the endometrial lining.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study

Exclusion criteria

• Any ongoing medication or medical condition smoking >20 cigarettes per day BMI >30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Standard treatment

No Intervention group

Description:

patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally

trilostane

Active Comparator group

Description:

patients will receive Day 1: Mifepristone 200 mg and Trilostane 120mg 1 tablet twice and Day 2 Trilostane 240mg twice. On Day 3 800 mcg misoprostol will be given vaginally.

Treatment:

Drug: Trilostane

Letrozole

Active Comparator group

Description:

Patients will receive on Day 1 Mifepristone 200mg and Letrozole 2,5mg 3 tablets and on Day 2 Letrozole 2,5mg 3 tablets. On day 3 800mcg of misoprostol will be given vaginally

Treatment:

Drug: Letrozole