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

December 8, 2015 updated by: Dr. Lee Chi Yan Vivian, The University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Letrozole group
Letrozole 10 mg daily for 7 days before suction evacuation
Drug: Letrozole
letrozole 10 mg daily for 7 days before suction evacuation
Other Names:
  • Letrozole group
Placebo Comparator: Placebo group
Placebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation
Drug: Placebo
placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation
Other Names:
  • Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Vivian CY Lee, MBBS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 12-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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