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Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Phase 2 trial testing Anastrozole 1 mg in Anovulation in 271 participants. Completed in 12 December 2007.
| Lead sponsor | EMD Serono |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 271 |
| Start date | 10 March 2005 |
| Primary completion | 12 December 2007 |
| Estimated completion | 12 December 2007 |
| Sites | 1 location across United States |
EMD Serono — full company profile →
Adults 18 to 40, female only, with Anovulation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| Clomiphene Citrate 50 mg | 64.9 | |
| Anastrozole 1 mg | 30.4 | |
| Anastrozole 5 mg | 36.8 | |
| Anastrozole 10 mg | 35.9 |
Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.
| Group | Value | 95% CI |
|---|---|---|
| Clomiphene Citrate 50 mg | 10 | |
| Anastrozole 1 mg | 4 | |
| Anastrozole 5 mg | 7 | |
| Anastrozole 10 mg | 0 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Clomiphene Citrate 50 mg (… | Anastrozole 1 mg (Cycle 1) | Anastrozole 5 mg (Cycle 1) | Anastrozole 10 mg (Cycle 1) | Clomiphene Citrate 50 mg (… | Clomiphene Citrate 100 mg … | Anastrozole 1 mg (Cycle 2) | Anastrozole 5 mg (Cycle 2) | Anastrozole 10 mg (Cycle 2) | Clomiphene Citrate 50 mg (… | Clomiphene Citrate 100 mg … | Anastrozole 1 mg (Cycle 3) | Anastrozole 5 mg (Cycle 3) | Anastrozole 10 mg (Cycle 3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Reaction | System | Clomiphene Citrate 50 mg (… | Anastrozole 1 mg (Cycle 1) | Anastrozole 5 mg (Cycle 1) | Anastrozole 10 mg (Cycle 1) | Clomiphene Citrate 50 mg (… | Clomiphene Citrate 100 mg … | Anastrozole 1 mg (Cycle 2) | Anastrozole 5 mg (Cycle 2) | Anastrozole 10 mg (Cycle 2) | Clomiphene Citrate 50 mg (… | Clomiphene Citrate 100 mg … | Anastrozole 1 mg (Cycle 3) | Anastrozole 5 mg (Cycle 3) | Anastrozole 10 mg (Cycle 3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Adnexa uteri pain | Reproductive system and breast disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Hot flush | Vascular disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Breast tenderness | Reproductive system and breast disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Abortion spontaneous.
Data from ClinicalTrials.gov NCT00213148 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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