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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457312
• Other study ID #: UW 12-077
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2015
• Last updated: December 8, 2015
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Letrozole
letrozole 10 mg daily for 7 days before suction evacuation
• Placebo
placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.		8 days	No
Secondary	Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.		8 days	No