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

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 2

Conditions: Pregnancy

Treatments: Drug: Letrozole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02457312

UW 12-077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Letrozole group

Active Comparator group

Description:

Letrozole 10 mg daily for 7 days before suction evacuation

Treatment:

Drug: Letrozole

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo