NCT00213148

Brief Summary

The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
271

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2007

Completed
10.6 years until next milestone

Results Posted

Study results publicly available

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Results QC Date

September 21, 2017

Last Update Submit

September 21, 2017

Conditions

Anovulation

Outcome Measures

Primary Outcomes (1)

  • Ovulation Rate in Cycle 1

    Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron \[P4\] level greater than or equal to \[\>=\] 10 nanogram per milliliter \[ng/mL\] and/or pregnancy).

    Up to 1 month

Secondary Outcomes (1)

  • Number of Subjects With Clinical Pregnancy in Cycle 1

    Up to 1 month

Study Arms (5)

Clomiphene Citrate 50 Milligram (mg)

ACTIVE COMPARATOR
Drug: Clomiphene Citrate 50 mg

Clomiphene Citrate 100 mg

ACTIVE COMPARATOR
Drug: Clomiphene Citrate 100 mg

Anastrozole 1 mg

EXPERIMENTAL
Drug: Anastrozole 1 mg

Anastrozole 5 mg

EXPERIMENTAL
Drug: Anastrozole 5 mg

Anastrozole 10 mg

EXPERIMENTAL
Drug: Anastrozole 10 mg

Interventions

Anastrozole 1 mgDRUG

Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Anastrozole 1 mg
Anastrozole 5 mgDRUG

Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Anastrozole 5 mg
Anastrozole 10 mgDRUG

Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Anastrozole 10 mg
Clomiphene Citrate 50 mgDRUG

Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Clomiphene Citrate 50 Milligram (mg)
Clomiphene Citrate 100 mgDRUG

Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).

Clomiphene Citrate 100 mg

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-40 years
  • Ovulatory dysfunction characterized by irregular and/or extended cycles
  • Non-smoker

You may not qualify if:

  • No previous gonadotropin treatment
  • No more than 6 previous clomiphene treatment cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local US Medical Information

Rockland, Massachusetts, 02370, United States

Location

MeSH Terms

Conditions

Anovulation

Interventions

AnastrozoleClomiphene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
service@merckgroup.com
+49-6151-72-5200

Study Officials

  • Medical Responsible

    EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 10, 2005

Primary Completion

December 12, 2007

Study Completion

December 12, 2007

Last Updated

July 17, 2018

Results First Posted

July 17, 2018

Record last verified: 2017-09

Locations

US(1)