CLINICAL TRIALS PROFILE FOR ACTIVELLA

All Clinical Trials for Activella

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00919919 ↗	Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen	Unknown status	Ferring Pharmaceuticals	Phase 2	2009-06-01	The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
NCT00919919 ↗	Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen	Unknown status	Rabin Medical Center	Phase 2	2009-06-01	The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
NCT01157182 ↗	Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2007-02-01	The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting conditions.
NCT01181726 ↗	Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2007-01-01	The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fed conditions.
NCT01817530 ↗	Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)	Completed	AbbVie	Phase 2	2013-04-08	This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
NCT02693002 ↗	Estrogen Diastolic Heart Failure	Terminated	Gretchen Wells	Phase 4	2016-02-01	Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).
NCT03213457 ↗	A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain	Active, not recruiting	AbbVie	Phase 3	2017-07-07	The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Clinical Trial Conditions for Activella

Condition Name

Condition Name for Activella
Intervention	Trials
Healthy	2
Endometrial Cancer	1
Endometrial Hyperplasia	1
Endometriosis	1

Condition MeSH

Condition MeSH for Activella
Intervention	Trials
Endometrial Neoplasms	1
Uterine Hemorrhage	1
Endometrial Hyperplasia	1
Myofibroma	1

Clinical Trial Locations for Activella

Trials by Country

Trials by Country for Activella
Location	Trials
United States	66
Canada	5
Puerto Rico	2
Israel	1
Chile	1

Trials by US State

Trials by US State for Activella
Location	Trials
Kentucky	3
Georgia	2
Florida	2
District of Columbia	2
Colorado	2

Clinical Trial Progress for Activella

Clinical Trial Phase

Clinical Trial Phase for Activella
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Activella
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	1
Terminated	1

Clinical Trial Sponsors for Activella

Sponsor Name

Sponsor Name for Activella
Sponsor	Trials
Teva Pharmaceuticals USA	2
AbbVie	2
Ferring Pharmaceuticals	1

Sponsor Type

Sponsor Type for Activella
Sponsor	Trials
Industry	5
Other	2

Activella: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Activella, a combination hormone therapy consisting of estradiol and norethindrone acetate, is widely used for the treatment of menopausal symptoms and the prevention of postmenopausal osteoporosis. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Treatment of Moderate to Severe Vasomotor Symptoms

Clinical trials have demonstrated the efficacy of Activella in treating moderate to severe vasomotor symptoms due to menopause. In a 3-month study, Activella 1 mg/0.5 mg showed significant reduction in hot flashes and night sweats, improving the quality of life for postmenopausal women[4].

Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Activella is also indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy. Clinical trials have shown that it effectively alleviates symptoms such as vaginal dryness and pain during intercourse[4].

Prevention of Postmenopausal Osteoporosis

The drug has been shown to increase lumbar spine bone mineral density (BMD) in both US and European clinical trials, making it an effective option for the prevention of postmenopausal osteoporosis[4].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Clinical trials have identified several common adverse reactions associated with Activella, including back pain, headache, nausea, and vaginal hemorrhage. These reactions were reported at varying frequencies across different studies[1][4].

Serious Adverse Reactions

More serious adverse reactions include an increased risk of endometrial cancer with unopposed estrogen use, and an increased risk of probable dementia in postmenopausal women 65 years of age and older. There is also a risk of stroke and deep vein thrombosis (DVT) associated with estrogen-alone therapy[4].

Market Analysis

Authorized Generic and Cost Implications

Amneal Pharmaceuticals launched an Authorized Generic (AG) of Activella, known as Lopreeza, which contains the identical formulation of estradiol/norethindrone acetate. This move allows pharmacists to provide patients with the same brand product at a lower cost, enhancing affordability and continuity of therapy[2].

Market Competition

The market for menopausal treatments is competitive, with various hormonal and non-hormonal therapies available. However, Activella's combination of estradiol and norethindrone acetate positions it as a preferred option for women with a uterus, due to its balanced therapeutic profile and reduced risk of endometrial hyperplasia[1][4].

Market Projections

Patient Demand and Compliance

Given the efficacy and safety profile of Activella, it is likely to remain a popular choice among healthcare providers and patients. The availability of an Authorized Generic further enhances its market appeal by offering a cost-effective alternative without compromising on therapeutic consistency[2].

Future Trends in Menopausal Therapies

The menopausal treatment market is evolving, with ongoing research into new therapeutic options. However, established drugs like Activella are expected to maintain their market share due to their well-documented efficacy and safety profiles. As the population ages, the demand for effective menopausal treatments is anticipated to increase, benefiting drugs like Activella[4].

Regulatory Considerations

FDA Guidelines and Warnings

Activella is subject to FDA guidelines and warnings, particularly regarding the risks associated with estrogen and progestin therapy. Healthcare providers must carefully consider these risks when prescribing the medication, especially for the prevention of cardiovascular disease or dementia[4].

Key Takeaways

• Efficacy: Activella is effective in treating moderate to severe vasomotor symptoms, vulvar and vaginal atrophy, and preventing postmenopausal osteoporosis.
• Safety Profile: Common adverse reactions include back pain, headache, and nausea, with more serious risks such as endometrial cancer and dementia in older women.
• Market Analysis: The launch of an Authorized Generic enhances affordability and continuity of therapy, positioning Activella competitively in the market.
• Projections: Activella is expected to remain a preferred option due to its balanced therapeutic profile and the increasing demand for menopausal treatments.

FAQs

What are the primary indications for Activella?

Activella is indicated for the treatment of moderate to severe vasomotor symptoms, moderate to severe symptoms of vulvar and vaginal atrophy, and the prevention of postmenopausal osteoporosis[4].

What are the common adverse reactions associated with Activella?

Common adverse reactions include back pain, headache, nausea, and vaginal hemorrhage[1][4].

Is there an Authorized Generic available for Activella?

Yes, Amneal Pharmaceuticals has launched an Authorized Generic called Lopreeza, which contains the identical formulation of estradiol/norethindrone acetate[2].

What are the serious risks associated with Activella?

Serious risks include an increased risk of endometrial cancer, probable dementia in older women, stroke, and deep vein thrombosis (DVT)[4].

How does Activella compare to other menopausal treatments in the market?

Activella is a preferred option due to its balanced therapeutic profile and reduced risk of endometrial hyperplasia, making it a competitive choice in the menopausal treatment market[1][4].

Sources

1. RxList: Activella (Estradiol, Norethindrone Acetate) - RxList
2. Biospace: Amneal Pharmaceuticals Launches AG For Novo Nordisk A/S's Activella
3. FDA: APPLICATION NUMBER: - 216578Orig1s000 CLINICAL REVIEW(S)
4. FDA: ACTIVELLA (estradiol/norethindrone acetate) Label
5. CITELINE: Key Potential Drug Launches in 2025 - Citeline