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

NCT ID: NCT02457312

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Letrozole group

Letrozole 10 mg daily for 7 days before suction evacuation

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

letrozole 10 mg daily for 7 days before suction evacuation

Placebo group

Placebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation

Interventions

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Letrozole

letrozole 10 mg daily for 7 days before suction evacuation

Intervention Type DRUG

Placebo

placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation

Intervention Type DRUG

Other Intervention Names

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Letrozole group Placebo group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Lee Chi Yan Vivian

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivian CY Lee, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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UW 12-077

Identifier Type: -

Identifier Source: org_study_id