CompletedNCT00213148Updated Jul 17, 2018Results posted

Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

A Phase 2 interventional study of Anastrozole 1 mg and Anastrozole 5 mg in Anovulation, sponsored by EMD Serono. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by EMD Serono (part of Merck KGaA, Darmstadt, Germany) · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Mar 2005, registered Sep 2005).

Phase: Phase 2
Study type: Interventional
Enrollment: 271
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study 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.

Conditions studied

Anovulation

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Anovulation 75

In context

Anovulation

75 studies on the registry are indexed under Anovulation; 7 are open to participants now.

This study's enrollment of 271 is above the median of 80 across 52 interventional studies indexed under Anovulation.

Browse Anovulation studies →

Lead sponsor

EMD Serono is the lead sponsor of 91 studies on the registry; none are open to participants now.

First submitted before EMD Serono became part of Merck KGaA, Darmstadt, Germany.

Browse EMD Serono studies →All Merck KGaA, Darmstadt, Germany studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 271 participants (actual)

Study arms

Active comparator
Clomiphene Citrate 50 Milligram (mg)
Drug: Clomiphene Citrate 50 mg
Active comparator
Clomiphene Citrate 100 mg
Drug: Clomiphene Citrate 100 mg
Experimental
Anastrozole 1 mg
Drug: Anastrozole 1 mg
Experimental
Anastrozole 5 mg
Drug: Anastrozole 5 mg
Experimental
Anastrozole 10 mg
Drug: Anastrozole 10 mg

Interventions

DrugAnastrozole 1 mg
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).
DrugAnastrozole 5 mg
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).
DrugAnastrozole 10 mg
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).
DrugClomiphene Citrate 50 mg
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).
DrugClomiphene Citrate 100 mg
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).

What researchers measure

Primary outcomes

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).
Time frame: Up to 1 month

Secondary outcomes

Number of Subjects With Clinical Pregnancy in Cycle 1
Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.
Time frame: Up to 1 month

Results

Posted Jul 17, 2018

Participant flow

Cycle 1 (1 Month)

Participant flow — Cycle 1 (1 Month)
Milestone	Clomiphene Citrate 50 Milligram (mg)	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg
Started	77	79	76	39
Completed	53	60	58	17
Not completed	24	19	18	22
Withdrew: Lost to follow-up	1	2	2	1
Withdrew: Adverse event	0	1	0	0
Withdrew: Lack of efficacy	4	8	5	8
Withdrew: Protocol violation	1	1	0	0
Withdrew: Other	3	2	2	7
Withdrew: Pregnancy unrelated to therapy	0	0	1	0
Withdrew: Non resolving cyst > 25mm	0	0	0	1
Withdrew: Discontinued before start of cycle 2	15	5	8	5

Cycle 2 (1 Month)

Participant flow — Cycle 2 (1 Month)
Milestone	Clomiphene Citrate 50 Milligram (mg)	Clomiphene Citrate 100 mg	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg
Started	43	10	42	52	41
Completed	29	4	28	33	11
Not completed	14	6	14	19	30
Withdrew: Lost to follow-up	0	0	2	2	1
Withdrew: Lack of efficacy	1	3	7	6	16
Withdrew: Other	2	1	2	8	7
Withdrew: Pregnancy unrelated to therapy	0	1	0	0	0
Withdrew: Non resolving cyst > 25mm	1	0	0	0	0
Withdrew: Discontinued before start of cycle 3	10	1	3	3	6

Cycle 3 (1 Month)

Participant flow — Cycle 3 (1 Month)
Milestone	Clomiphene Citrate 50 Milligram (mg)	Clomiphene Citrate 100 mg	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg
Started	23	10	26	24	22
Completed	23	8	25	23	21
Not completed	0	2	1	1	1
Withdrew: Lost to follow-up	0	2	0	0	1
Withdrew: Other	0	0	1	1	0

Outcome measures

PrimaryOvulation 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).

Time frame:: Up to 1 month
Reported as:: Number · percentage of subjects

Ovulation Rate in Cycle 1
percentage of subjects	Clomiphene Citrate 50 mg	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg
Ovulation Rate in Cycle 1	64.9	30.4	36.8	35.9

SecondaryNumber of Subjects With Clinical Pregnancy in Cycle 1

Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.

Time frame:: Up to 1 month
Reported as:: Number · subjects

Number of Subjects With Clinical Pregnancy in Cycle 1
subjects	Clomiphene Citrate 50 mg	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg
Number of Subjects With Clinical Pregnancy in Cycle 1	10	4	7	0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Clomiphene Citrate 50 mg (Cycle 1)	—	1/77 (1.3%)	23/77 (29.9%)
Anastrozole 1 mg (Cycle 1)	—	0/79 (0%)	12/79 (15.2%)
Anastrozole 5 mg (Cycle 1)	—	0/76 (0%)	17/76 (22.4%)
Anastrozole 10 mg (Cycle 1)	—	0/39 (0%)	4/39 (10.3%)
Clomiphene Citrate 50 mg (Cycle 2)	—	0/43 (0%)	6/43 (14%)
Clomiphene Citrate 100 mg (Cycle 2)	—	0/10 (0%)	2/10 (20%)
Anastrozole 1 mg (Cycle 2)	—	0/42 (0%)	2/42 (4.8%)
Anastrozole 5 mg (Cycle 2)	—	0/52 (0%)	4/52 (7.7%)
Anastrozole 10 mg (Cycle 2)	—	0/41 (0%)	7/41 (17.1%)
Clomiphene Citrate 50 mg (Cycle 3)	—	0/23 (0%)	4/23 (17.4%)
Clomiphene Citrate 100 mg (Cycle 3)	—	0/10 (0%)	2/10 (20%)
Anastrozole 1 mg (Cycle 3)	—	0/26 (0%)	1/26 (3.8%)
Anastrozole 5 mg (Cycle 3)	—	0/24 (0%)	2/24 (8.3%)
Anastrozole 10 mg (Cycle 3)	—	0/22 (0%)	2/22 (9.1%)

Most frequent serious events

Most frequent serious events
Event	Clomiphene Citrate 50 mg (Cycle 1)	Anastrozole 1 mg (Cycle 1)	Anastrozole 5 mg (Cycle 1)	Anastrozole 10 mg (Cycle 1)	Clomiphene Citrate 50 mg (Cycle 2)	Clomiphene Citrate 100 mg (Cycle 2)	Anastrozole 1 mg (Cycle 2)	Anastrozole 5 mg (Cycle 2)	Anastrozole 10 mg (Cycle 2)	Clomiphene Citrate 50 mg (Cycle 3)	Clomiphene Citrate 100 mg (Cycle 3)	Anastrozole 1 mg (Cycle 3)	Anastrozole 5 mg (Cycle 3)	Anastrozole 10 mg (Cycle 3)
Abortion spontaneousPregnancy, puerperium and perinatal conditions	1/77	0/79	0/76	0/39	0/43	0/10	0/42	0/52	0/41	0/23	0/10	0/26	0/24	0/22

Most frequent other events

Most frequent other events
Event	Clomiphene Citrate 50 mg (Cycle 1)	Anastrozole 1 mg (Cycle 1)	Anastrozole 5 mg (Cycle 1)	Anastrozole 10 mg (Cycle 1)	Clomiphene Citrate 50 mg (Cycle 2)	Clomiphene Citrate 100 mg (Cycle 2)	Anastrozole 1 mg (Cycle 2)	Anastrozole 5 mg (Cycle 2)	Anastrozole 10 mg (Cycle 2)	Clomiphene Citrate 50 mg (Cycle 3)	Clomiphene Citrate 100 mg (Cycle 3)	Anastrozole 1 mg (Cycle 3)	Anastrozole 5 mg (Cycle 3)	Anastrozole 10 mg (Cycle 3)
HeadacheNervous system disorders	9/77	5/79	9/76	2/39	0/43	0/10	1/42	1/52	3/41	2/23	0/10	1/26	1/24	2/22
Adnexa uteri painReproductive system and breast disorders	6/77	2/79	4/76	0/39	2/43	1/10	0/42	0/52	1/41	2/23	0/10	0/26	0/24	0/22
Hot flushVascular disorders	0/77	0/79	0/76	0/39	3/43	1/10	0/42	2/52	0/41	0/23	1/10	0/26	1/24	0/22
Breast tendernessReproductive system and breast disorders	0/77	0/79	0/76	0/39	0/43	0/10	0/42	0/52	0/41	0/23	1/10	0/26	0/24	0/22
NauseaGastrointestinal disorders	4/77	5/79	2/76	2/39	1/43	0/10	1/42	1/52	3/41	0/23	0/10	0/26	0/24	0/22
Back painMusculoskeletal and connective tissue disorders	4/77	0/79	2/76	0/39	0/43	0/10	0/42	0/52	0/41	0/23	0/10	0/26	0/24	0/22

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Clomiphene Citrate 50 mg	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg	Total
Mean	29.0 ± 3.9	28.8 ± 3.9	29.6 ± 3.9	29.3 ± 3.4	29.2 ± 3.8

Sex: Female, Male
Sex: Female, Male(Participants)	Clomiphene Citrate 50 mg	Anastrozole 1 mg	Anastrozole 5 mg	Anastrozole 10 mg	Total
Female	77	79	76	39	271
Male	0	0	0	0	0

Study locations

1 site

Local US Medical Information
Rockland, Massachusetts 02370, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00213148
Lead sponsor: EMD Serono
Responsible party: Sponsor
First posted: Sep 21, 2005
Start date: Mar 10, 2005
Primary completion: Dec 12, 2007
Completion: Dec 12, 2007
Results posted: Jul 17, 2018
Last update: Jul 17, 2018

Study contacts

Medical Responsible

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

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Anastrozole · Clomiphene

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