CLINICAL TRIALS PROFILE FOR ESTROGENS, CONJUGATED SYNTHETIC B

All Clinical Trials for Estrogens, Conjugated Synthetic B

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006133 ↗	Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus	Completed	University of Alabama at Birmingham	N/A	2000-06-01	OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive, stable, or moderate systemic lupus erythematosus (SLE). II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.
NCT00006133 ↗	Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus	Completed	National Center for Research Resources (NCRR)	N/A	2000-06-01	OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive, stable, or moderate systemic lupus erythematosus (SLE). II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.
NCT00196378 ↗	A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy	Completed	Duramed Research	Phase 3	2004-11-01	This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
NCT00272935 ↗	A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes	Completed	Duramed Research	Phase 3	2005-12-01	This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.
NCT00357006 ↗	A Definitive Estrogen Patch Study (ADEPT)	Completed	Stanley Medical Research Institute	Phase 2	2006-07-01	OBJECTIVE: To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia. HYPOTHESIS: That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo. STUDY POPULATION: 180 women will be recruited over a three-year period across three sites. Participant will be of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)according to the Mini International Neuropsychiatric Interview (MINI). STUDY MEDICATION: Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive 100mcg Estradiol; one third of the participants (n=60) will be randomised to receive adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be randomised to receive adjunctive placebo n=60). All patches will be covered with identical adhesive contact to ensure the "blind" is maintained. STUDY EVALUATIONS: Data will be collected over a two-month period for each participant. Visits will be performed at baseline, and then at weekly or fortnightly intervals. A total of six visits will be completed for each participant. The following evaluations will be performed: i) Inclusion/exclusion checklist. (Baseline visit only) ii) Informed consent. (Baseline visit only) iii)psychiatric evaluation to determine diagnosis. (Baseline visit only) iv) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits) v) Medication history. (Baseline and evaluation visits) vi) Demographics. (Baseline visits only) vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS), which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure changes in subject's reported side effects during the trial. viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen, Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits).
NCT00357006 ↗	A Definitive Estrogen Patch Study (ADEPT)	Completed	The Alfred	Phase 2	2006-07-01	OBJECTIVE: To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia. HYPOTHESIS: That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo. STUDY POPULATION: 180 women will be recruited over a three-year period across three sites. Participant will be of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)according to the Mini International Neuropsychiatric Interview (MINI). STUDY MEDICATION: Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive 100mcg Estradiol; one third of the participants (n=60) will be randomised to receive adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be randomised to receive adjunctive placebo n=60). All patches will be covered with identical adhesive contact to ensure the "blind" is maintained. STUDY EVALUATIONS: Data will be collected over a two-month period for each participant. Visits will be performed at baseline, and then at weekly or fortnightly intervals. A total of six visits will be completed for each participant. The following evaluations will be performed: i) Inclusion/exclusion checklist. (Baseline visit only) ii) Informed consent. (Baseline visit only) iii)psychiatric evaluation to determine diagnosis. (Baseline visit only) iv) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits) v) Medication history. (Baseline and evaluation visits) vi) Demographics. (Baseline visits only) vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS), which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure changes in subject's reported side effects during the trial. viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen, Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits).
NCT00361569 ↗	A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy	Completed	Duramed Research	Phase 3	2006-08-01	This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Clinical Trial Conditions for Estrogens, Conjugated Synthetic B

Condition Name

Condition Name for Estrogens, Conjugated Synthetic B
Intervention	Trials
Menopause	2
Nocturnal Vasomotor Symptoms	1
Schizoaffective Disorder	1
Schizophrenia	1

Condition MeSH

Condition MeSH for Estrogens, Conjugated Synthetic B
Intervention	Trials
Atrophy	2
Disease	1
Hot Flashes	1
Lupus Erythematosus, Systemic	1

Clinical Trial Locations for Estrogens, Conjugated Synthetic B

Trials by Country

Trials by Country for Estrogens, Conjugated Synthetic B
Location	Trials
United States	98
Australia	1

Trials by US State

Trials by US State for Estrogens, Conjugated Synthetic B
Location	Trials
Texas	5
Pennsylvania	5
California	5
Florida	4
North Carolina	4

Clinical Trial Progress for Estrogens, Conjugated Synthetic B

Clinical Trial Phase

Clinical Trial Phase for Estrogens, Conjugated Synthetic B
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Estrogens, Conjugated Synthetic B
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for Estrogens, Conjugated Synthetic B

Sponsor Name

Sponsor Name for Estrogens, Conjugated Synthetic B
Sponsor	Trials
Duramed Research	4
University of Alabama at Birmingham	1
National Center for Research Resources (NCRR)	1

Sponsor Type

Sponsor Type for Estrogens, Conjugated Synthetic B
Sponsor	Trials
Industry	4
Other	3
NIH	1

Estrogens, Conjugated Synthetic B: Clinical Trials, Market Analysis, and Projections

Introduction to Estrogens, Conjugated Synthetic B

Estrogens, Conjugated Synthetic B, often referred to as Synthetic Conjugated Estrogens, B, is a mixture of ten synthetic estrogenic substances derived from plant sources such as yam or soy. This formulation is designed to mimic the natural estrogens found in the body and is used to treat various postmenopausal symptoms.

Clinical Trials Overview

Efficacy in Vasomotor Symptoms

Clinical trials have demonstrated the efficacy of Synthetic Conjugated Estrogens, B in reducing vasomotor symptoms in postmenopausal women. A randomized, double-blind, placebo-controlled trial involving 281 highly symptomatic menopausal women showed that all three dosage strengths (0.3 mg, 0.625 mg, and 1.25 mg) of Synthetic Conjugated Estrogens, B significantly reduced the frequency and severity of hot flushes compared to placebo over a 12-week period[1].

Impact on Nocturnal Vasomotor Symptoms

Another study focused on the effect of Synthetic Conjugated Estrogens, B on nocturnal vasomotor symptoms. This trial, involving 157 postmenopausal women, found that both the 0.3 mg and 0.625 mg doses significantly reduced the frequency of awakenings due to hot flushes and improved sleep quality[4].

Safety Profile

The safety profile of Synthetic Conjugated Estrogens, B has been evaluated in these trials. The most commonly reported adverse events were headaches, with no significant difference in the incidence of treatment-related adverse events between the active treatment and placebo groups[1].

Market Analysis

Current Market Position

Synthetic Conjugated Estrogens, B, marketed under brand names such as Enjuvia, is a significant player in the hormone replacement therapy (HRT) market. It offers an alternative to conjugated equine estrogens (CEEs), which are derived from pregnant mares’ urine. The plant-derived nature of Synthetic Conjugated Estrogens, B may appeal to patients and healthcare providers looking for a non-animal source of estrogen therapy[2].

Competitive Landscape

The HRT market is competitive, with various estrogen products available, including CEEs and other synthetic estrogens. However, Synthetic Conjugated Estrogens, B stands out due to its plant-derived composition and the comprehensive clinical data supporting its efficacy and safety.

Market Trends

There is a growing trend towards personalized medicine and patient preference for natural or plant-derived products. This trend is likely to favor the growth of Synthetic Conjugated Estrogens, B in the market. Additionally, the increasing awareness of menopausal symptoms and the importance of HRT in improving quality of life for postmenopausal women are expected to drive market demand.

Projections and Future Outlook

Market Growth

The global HRT market is projected to grow significantly over the next few years, driven by an aging population and increasing awareness of menopausal health. Synthetic Conjugated Estrogens, B is expected to capture a substantial share of this growing market due to its efficacy, safety profile, and patient preference for plant-derived products.

Regulatory Environment

The FDA has provided guidelines for the development of generic versions of conjugated estrogens, which could impact the market dynamics. However, the unique composition and clinical data supporting Synthetic Conjugated Estrogens, B are likely to maintain its market position even with the entry of generics[5].

Emerging Opportunities

There is an opportunity for further research and development to expand the indications for Synthetic Conjugated Estrogens, B. For example, studies could explore its use in preventing or treating other menopausal symptoms such as vaginal dryness and osteoporosis.

Risks and Considerations

Thromboembolic Risks

Like other estrogen therapies, Synthetic Conjugated Estrogens, B carries risks such as venous thromboembolism (VTE). Clinical trials and observational studies have shown that estrogen therapy can increase the risk of VTE, particularly in the first year of treatment[3].

Breast and Endometrial Cancer Risks

Estrogen therapy is also associated with risks of breast and endometrial cancer. The Women's Health Initiative (WHI) studies have provided extensive data on these risks, highlighting the importance of careful patient selection and monitoring[3].

Key Takeaways

• Efficacy: Synthetic Conjugated Estrogens, B is effective in reducing vasomotor symptoms and improving sleep quality in postmenopausal women.
• Safety: The safety profile is generally favorable, with headaches being the most common adverse event.
• Market Position: It is a significant player in the HRT market, offering a plant-derived alternative to CEEs.
• Growth Projections: Expected to grow with the increasing demand for HRT and preference for plant-derived products.
• Regulatory Environment: FDA guidelines may impact market dynamics, but unique clinical data supports its market position.
• Risks: Associated with thromboembolic and cancer risks, necessitating careful patient selection and monitoring.

FAQs

What is Synthetic Conjugated Estrogens, B used for?

Synthetic Conjugated Estrogens, B is used to treat various postmenopausal symptoms, including hot flushes, nocturnal vasomotor symptoms, and vaginal dryness.

How is Synthetic Conjugated Estrogens, B different from other estrogen therapies?

It is derived from plant sources such as yam or soy, unlike conjugated equine estrogens which are derived from pregnant mares’ urine.

What are the common side effects of Synthetic Conjugated Estrogens, B?

The most commonly reported adverse events are headaches.

Does Synthetic Conjugated Estrogens, B increase the risk of breast cancer?

Estrogen therapy, including Synthetic Conjugated Estrogens, B, can increase the risk of breast cancer, particularly with long-term use and in combination with progestin.

How does Synthetic Conjugated Estrogens, B affect sleep in postmenopausal women?

It significantly reduces the frequency of awakenings due to nocturnal hot flushes and improves sleep quality.

Sources

1. PubMed: Relief of hot flushes with new plant-derived 10-component synthetic conjugated estrogens.
2. DrugBank: Synthetic Conjugated Estrogens, B.
3. FDA: Premarin® (conjugated estrogens) Vaginal Cream.
4. PubMed: Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms.
5. FDA: Draft Guidance on Conjugated Estrogens.