NCT02341703

Brief Summary

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin with that of combined letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

January 14, 2015

Last Update Submit

July 27, 2015

Conditions

Polycystic Ovary SyndromeInfertility

Outcome Measures

Primary Outcomes (1)

  • ovulation rate

    6 months

Secondary Outcomes (1)

  • pregnancy rate

    6 months

Study Arms (2)

letrozole-metformin group

ACTIVE COMPARATOR

this group will receive letrozole 2.5 mg daily from day 3 of the cycle and for 5 days + metformin 500 mg three times daily from the first day of the cycle and continuous for three months unless pregnancy occurred. treatment will continue for 3 cycles unless pregnancy occurred. for this group: transvaginal ultrasound will monitor follicular enlargement laboratory investigations in the form of day 3 FSH, LH, TSH and serum testosterone will be done day 12 E2 day 21 serum progesterone

Drug: letrozole-metforminRadiation: transvaginal ultrasoundOther: laboratory investigations

letrozole-metformin-pioglitazone group

ACTIVE COMPARATOR

this group will receive letrozole 2.5 mg daily from day 3 of the cycle and for 5 days + (metformin 850 mg + pioglitazone 15 mg) once daily from the first day of the cycle and for 10 days. treatment will continue for 3 cycles unless pregnancy occurred. for this group: transvaginal ultrasound will monitor follicular enlargement laboratory investigations in the form of day 3 FSH, LH, TSH and serum testosterone will be done day 12 E2 day 21 serum progesterone

Drug: letrozole-metformin-pioglitazoneRadiation: transvaginal ultrasoundOther: laboratory investigations

Interventions

letrozole-metforminDRUG

letrozole 2.5 mg will be given daily from day 3 of the cycle for 5 days + metformin 500 mg three times daily continuously for 3 months unless pregnancy occurred

Also known as: femara-cidophage
letrozole-metformin group
letrozole-metformin-pioglitazoneDRUG

letrozole will be given daily from day 3 of the cycle for 5 days + (metformin 850 mg + pioglitazone 15 mg) from the first day of the cycle for 10 days.

Also known as: femara- bioglita plus
letrozole-metformin-pioglitazone group
transvaginal ultrasoundRADIATION

transvaginal ultrasound will be done from day 10 of the cycle and every other day for monitoring of follicular enlargement.

letrozole-metformin groupletrozole-metformin-pioglitazone group
laboratory investigationsOTHER

day 3: FSH, LH, TSH, and total testosterone day 12 serum E2 day 21 serum progesterone

letrozole-metformin groupletrozole-metformin-pioglitazone group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • PCOS infertile women resistant to CC for 3 cycles

You may not qualify if:

  • Presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction
  • Use of gonadotropins before
  • Previous ovarian drilling
  • Presence of urinary symptoms especially bloody urine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine, Cairo University

Cairo, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ghada Abdel Fattah Abdel Moety, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

EG(1)