The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues

Phase 2

Completed

• Conditions: Pregnancy
• Interventions: Drug: Placebo; Drug: Letrozole

• Registration Number: NCT02457312
• Lead Sponsor: The University of Hong Kong

Brief Summary

The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors.

Detailed Description

Twenty healthy subjects requesting legal surgical abortion up to 63 days gestation will be recruited for this study. They will be randomized to receive either placebo tablets or letrozole 10 mg daily for 7 days before suction evacuation. Suction evacuates which include the placenta and some decidua collected by the procedure in these 20 subjects will be used for the laboratory studies.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-05
• Study Completion: 2013-12
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• The gestational age should be up to 63 days. An ultrasound assessment would be performed to confirm the gestation.
• The woman is willing and able to participate after the study has been explained
• Age >18 years old

Exclusion Criteria

• Criteria for prospective exclusion

Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions is present:

1. multiple pregnancies

2. uterine fibroids

3. any significant medical disorder

4. intrauterine contraceptive device in situ

5. contra-indications to the use of letrozole or misoprostol

   • Criteria for exclusion from a secondary analysis

Situation in which subjects who have been formally admitted to the study could be excluded from a secondary analysis include:

1. the use of drugs other than those prescribed by the investigator for the treatment of possible therapy-related side-effects especially drugs with prostaglandin synthetase inhibitory activity such as salicylates, indomethacin or mefenamic acid
2. any violation of the study protocol
3. essential data missing from the subject's records making it impossible to judge the treatment outcome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation
Letrozole group	Letrozole	Letrozole 10 mg daily for 7 days before suction evacuation

Primary Outcome Measures

Name	Time	Method
The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.	8 days

Secondary Outcome Measures

Name	Time	Method
Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.	8 days

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China