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

NCT02457312 | Completed Phase 2

• 1 other identifier: UW 12-077
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

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

  8 days

Secondary Outcomes (1)

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

  8 days

Study Arms (2)

Letrozole group

ACTIVE COMPARATOR

Letrozole 10 mg daily for 7 days before suction evacuation

Drug: Letrozole

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Letrozole DRUG

letrozole 10 mg daily for 7 days before suction evacuation

Also known as: Letrozole group

Letrozole group

Placebo DRUG

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

Also known as: Placebo group

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vivian CY Lee, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 29, 2015
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

CN (1)