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Completed

NCT Number: NCT02457312

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Queen Mary Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • multiple pregnancies
  • uterine fibroids
  • any significant medical disorder
  • intrauterine contraceptive device in situ
  • 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:

  • 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
  • any violation of the study protocol
  • essential data missing from the subject's records making it impossible to judge the treatment outcome

Treatment and study plan

letrozole

Drug

letrozole 10 mg daily for 7 days before suction evacuation

Other names: Letrozole group

Placebo

Drug

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

Other names: Placebo group

Primary outcomes

  1. The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.

    Time frame: 8 days

Secondary outcomes

  1. Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 29, 2015
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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