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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Letrozole; Misoprostol

Criteria

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