MILOPHENE (clomiphene citrate)
MILOPHENE is indicated for the treatment of Ovulatory Dysfunction; Polycystic Ovary Syndrome; Amenorrhea-Galactorrhea Syndrome; Psychogenic Amenorrhea; Secondary Amenorrhea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1988-12-20
- Routes
- ORAL
- Dosage Forms
- TABLET
MILOPHENE Approval History
What MILOPHENE Treats
5 indicationsMILOPHENE is approved for 5 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ovulatory Dysfunction
- Polycystic Ovary Syndrome
- Amenorrhea-Galactorrhea Syndrome
- Psychogenic Amenorrhea
- Secondary Amenorrhea
MILOPHENE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MILOPHENE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03059173 MYOPK | 2015_68 2016-A01246-45, PHRC_N_15-0116 | Ph 3 | recruiting | Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome |
| NCT04944836 | RCRHRT | Ph 2 | recruiting | Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial |
| NCT06701071 | HS-23-00039 | Ph 4 | recruiting | Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation |
| NCT05206448 CLC II results posted | 201906826 | Ph 4 | active not recruiting | Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation |
| NCT06564961 | 4068 | Ph 3 | completed | Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia |
| NCT00427700 results posted | RACLO | Ph 3 | completed | Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome |
| NCT02523898 | SemnanUMS1 | Ph 2 | terminated | Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant |
| NCT02436226 | MT1 | Ph 4 | completed | Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS |
| NCT05231980 | 86 | Ph 2 | completed | Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate |
| NCT04177693 results posted | 2000028370 1R01HD100369-01 | Ph 1 | completed | Pharmacokinetics and Hepatic Safety of EGCG |
| NCT04306692 | 2018-004604-20 | Ph 4 | terminated | Myo-inositol Versus Clomiphene Citrate in PCOS |
| NCT04210765 | 2019.08.1.04.061 | Ph 4 | completed | Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels |
| NCT04302532 | 1 | Ph 4 | completed | Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS |
| NCT03674385 | PHCL 191 | Ph 2 | completed | Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate |
| NCT03770026 | 181210 | Ph 2, Ph 3 | completed | Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium |
| NCT02274311 results posted | ClomipheneAcro | Ph 2 | completed | Clomiphene Citrate for Treatment of Acromegaly |
| NCT01880086 results posted | Cornell-1301013472 | Ph 2 | completed | Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration |
| NCT00719186 PPCOSII results posted | RMN-PPCOSII | Ph 3 | completed | Pregnancy in Polycystic Ovary Syndrome II |
| NCT01008319 Clomid results posted | 2078 | Ph 3 | completed | Traditional Clomiphene Citrate Administration vs. Stair-step Approach |
| NCT02380755 | 385.615 2013/16781-1 | Ph 2 | completed | Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism |
| NCT02775734 NAC | AS1275 | Ph 2, Ph 3 | completed | NAC in CC Resistant PCOS After LOD |
| NCT02352597 PCOS | 222 | Ph 4 | completed | Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS |
| NCT02381184 | khalid-walid | Ph 2, Ph 3 | completed | Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome |
| NCT02479256 | 20092009 | Ph 4 | completed | Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs |
| NCT00796289 | 2008-03 | Ph 2 | completed | Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females |
| NCT01638988 | OVO-12-17 | Ph 3 | withdrawn | Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin |
| NCT01044862 AMIGOS results posted | RMN-AMIGOS 3U10HD055925-02S1, 5U10HD055925 | Ph 3 | completed | Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation |
| NCT00501839 | 05/2006a | Ph 4 | withdrawn | Clomiphene Citrate in Infertile PCOS Patients |
| NCT00835744 cc versus FSH | 2008/192 | Ph 4 | completed | Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles |
| NCT01004068 | 06/2009 | Ph 4 | completed | Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS) |
| NCT01213147 | 2063 | Ph 4 | completed | Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders |
| NCT00830492 | YazdRCCI1388 | Ph 4 | completed | Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MILOPHENE FDA Label Details
Indications & Usage
MILOPHENE is indicated for the treatment of Ovulatory Dysfunction; Polycystic Ovary Syndrome; Amenorrhea-Galactorrhea Syndrome; Psychogenic Amenorrhea; Secondary Amenorrhea.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment